Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
Study NCT ID:
NCT01396395
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2011-07-15
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020108', 'term': 'Nicorandil'}], 'ancestors': [{'id': 'D009566', 'term': 'Nitrates'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Serono, a division of Merck KGaA'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks ).', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).', 'otherNumAtRisk': 197, 'otherNumAffected': 12, 'seriousNumAtRisk': 197, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.', 'otherNumAtRisk': 205, 'otherNumAffected': 1, 'seriousNumAtRisk': 205, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}], 'seriousEvents': [{'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cardiac sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Unstable angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': "Gastroenteritis'", 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Increased blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Chronic renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Myocardial Ischemia Attacks in 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '8.46', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '18.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.503', 'ciLowerLimit': '0.435', 'ciUpperLimit': '0.581', 'statisticalMethod': 'poisson regression: Non-calibration mode', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '=0.0086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.503', 'ciLowerLimit': '0.301', 'ciUpperLimit': '0.840', 'statisticalMethod': 'Poisson regression: Calibration model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At Week 12', 'description': 'Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (\\>=) 0.1 millivolts (mV), and lasted for \\>= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.', 'unitOfMeasure': 'ischemic attacks per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Myocardial Ischemic Burden at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.63', 'spread': '572.807', 'groupId': 'OG000'}, {'value': '29.26', 'spread': '404.070', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours.', 'unitOfMeasure': 'millimeter*minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum ST-depression at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '3.598', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '3.563', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Longest Duration of ST Segment Depression at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '37.75', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '18.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.'}, {'type': 'SECONDARY', 'title': 'Heart Rate Variability (HRV) Rate: Time Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'title': 'SDNN-24 hour (n=141, 149)', 'categories': [{'measurements': [{'value': '126.1', 'spread': '35.58', 'groupId': 'OG000'}, {'value': '125.7', 'spread': '33.25', 'groupId': 'OG001'}]}]}, {'title': 'SDANN index (n=141, 149)', 'categories': [{'measurements': [{'value': '116.9', 'spread': '37.44', 'groupId': 'OG000'}, {'value': '116.7', 'spread': '33.65', 'groupId': 'OG001'}]}]}, {'title': 'SDNN index (n=140, 147)', 'categories': [{'measurements': [{'value': '47.6', 'spread': '14.60', 'groupId': 'OG000'}, {'value': '47.0', 'spread': '14.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 12', 'description': "HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means.", 'unitOfMeasure': 'millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. "n" signifies the number of subjects evaluable for each category in each group for this outcome measure, respectively.'}, {'type': 'SECONDARY', 'title': 'Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '2397.0', 'spread': '1527.37', 'groupId': 'OG000'}, {'value': '2328.6', 'spread': '1458.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 12', 'description': "HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours.", 'unitOfMeasure': 'millisecond square (ms^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Arrhythmia Occurred Within 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'title': 'Ventricular tachycardia', 'categories': [{'measurements': [{'value': '0.8', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '40.67', 'groupId': 'OG001'}]}]}, {'title': 'Premature ventricular beat', 'categories': [{'measurements': [{'value': '134.8', 'spread': '457.59', 'groupId': 'OG000'}, {'value': '569.1', 'spread': '2538.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 12', 'description': 'The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours.', 'unitOfMeasure': 'beats per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'ECG QT Dispersion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1298', 'spread': '0.17240', 'groupId': 'OG000'}, {'value': '0.1110', 'spread': '0.15865', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 12', 'description': 'The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12-lead ECG.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Experienced Angina Attack', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 12 Weeks', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Frequency of Angina Attack', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 12', 'description': 'The total number of times angina attacks occurred within a week (number of times/week)', 'unitOfMeasure': 'angina attacks per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Nitroglycerin Tablets Consumed in a Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 12', 'unitOfMeasure': 'tablets per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Walk Distance in Six Minute Walk (6-MWT) Test at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '452.1', 'spread': '116.87', 'groupId': 'OG000'}, {'value': '438.1', 'spread': '107.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 12', 'description': 'The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )', 'description': 'An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Showed Compliance to Nicorandil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 12 Weeks', 'description': 'Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 milligram (mg) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors (ACEIs) as permitted by disease condition or as per standard local practices or prescribed per discretion of the investigators.'}, {'id': 'FG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '202'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'comment': '1 subject randomized to standard was included in standard+nicorandil as nicorandil was received.', 'groupId': 'FG000', 'numSubjects': '197'}, {'comment': '4 subjects randomized to standard+nicorandil were included in standard as no nicorandil was received', 'groupId': 'FG001', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received. Thus, safety set have 197 and 205 in Standard+nicorandil and standard group, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Treatment Plus Nicorandil', 'description': 'The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[ACEIs\\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}, {'id': 'BG001', 'title': 'Standard Treatment', 'description': 'The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '10.16', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '9.94', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '10.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized subjects who received at least one dose of study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2011-07-15', 'resultsFirstSubmitDate': '2015-09-14', 'studyFirstSubmitQcDate': '2011-07-15', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-15', 'studyFirstPostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Myocardial Ischemia Attacks in 24 Hours', 'timeFrame': 'At Week 12', 'description': 'Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (\\>=) 0.1 millivolts (mV), and lasted for \\>= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Myocardial Ischemic Burden at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours.'}, {'measure': 'Change From Baseline in Maximum ST-depression at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation.'}, {'measure': 'Change From Baseline in Longest Duration of ST Segment Depression at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack.'}, {'measure': 'Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test', 'timeFrame': 'At Week 12', 'description': 'The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.'}, {'measure': 'Heart Rate Variability (HRV) Rate: Time Domain', 'timeFrame': 'At Week 12', 'description': "HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means."}, {'measure': 'Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour', 'timeFrame': 'At Week 12', 'description': "HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours."}, {'measure': 'Number of Arrhythmia Occurred Within 24 Hours', 'timeFrame': 'At Week 12', 'description': 'The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours.'}, {'measure': 'ECG QT Dispersion', 'timeFrame': 'At Week 12', 'description': 'The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12-lead ECG.'}, {'measure': 'Number of Subjects Experienced Angina Attack', 'timeFrame': 'Baseline up to 12 Weeks'}, {'measure': 'Frequency of Angina Attack', 'timeFrame': 'At Week 12', 'description': 'The total number of times angina attacks occurred within a week (number of times/week)'}, {'measure': 'Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin', 'timeFrame': 'At Week 12'}, {'measure': 'Number of Nitroglycerin Tablets Consumed in a Week', 'timeFrame': 'At Week 12'}, {'measure': 'Walk Distance in Six Minute Walk (6-MWT) Test at Week 12', 'timeFrame': 'At Week 12', 'description': 'The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.'}, {'measure': 'Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation', 'timeFrame': 'From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )', 'description': 'An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Subjects Who Showed Compliance to Nicorandil', 'timeFrame': 'Baseline up to 12 Weeks', 'description': 'Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated.'}]}, 'conditionsModule': {'keywords': ['Nicorandil', 'Stable angina'], 'conditions': ['Stable Angina', 'Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '27657471', 'type': 'DERIVED', 'citation': 'Jiang J, Li Y, Zhou Y, Li X, Li H, Tang B, Dai X, Ma T, Li L, Huo Y. Oral nicorandil reduces ischemic attacks in patients with stable angina: A prospective, multicenter, open-label, randomized, controlled study. Int J Cardiol. 2016 Dec 1;224:183-187. doi: 10.1016/j.ijcard.2016.08.305. Epub 2016 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be diagnosed as stable CHD, and must have at least one of these histories:\n\n 1. A history of coronary revascularization Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery at least 3 months ago\n 2. Myocardial infarction\n 3. More than 50 percent (%) stenosis detected by angiography\n 4. Exercise Tolerance Testing (ETT) or Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms\n* Subjects must have at least 2 times of typical symptoms of myocardial ischemia occurred within a week Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Coronary syndrome or considering acute coronary syndrome (ACS)\n* Left main coronary artery disease without revascularization\n* Aortic stenosis\n* Obstructive hypertrophic cardiomyopathy\n* Subjects with hypertension systolic blood pressure (SBP) greater than (\\>) 170 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) \\>100 mmHg) or hypotension (SBP less than \\[\\<\\] 90 mmHg or DBP\\<60 mmHg)\n* Diagnosis as postural hypotension before\n* Congestive heart failure (New York Heart Association \\[NYHA\\] class III - IV\n* Ejection fraction (EF)\\<40% by Echocardiography\n* Arrhythmias requiring active treatment\n* Gastro-intestinal ulcer\n* Concomitant medication such as Sulphonyl urea, PDE-5 inhibitor such as sildenafil, Trimetazidine for treatment of angina pectoris Other protocol defined exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT01396395', 'acronym': 'SIGMART', 'briefTitle': 'Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina', 'orgStudyIdInfo': {'id': 'EMR200101-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard treatment plus nicorandil', 'description': 'The subjects will receive nicorandil 5 milligram (mg ) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (such as aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \\[(ACEIs\\] as permitted by disease condition /as per standard local practices/prescribed per discretion of investigators).', 'interventionNames': ['Drug: Nicorandil', 'Drug: Standard Treatment']}, {'type': 'OTHER', 'label': 'Standard treatment', 'interventionNames': ['Drug: Standard Treatment']}], 'interventions': [{'name': 'Nicorandil', 'type': 'DRUG', 'description': 'The subjects will receive Nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with the standard treatment.', 'armGroupLabels': ['Standard treatment plus nicorandil']}, {'name': 'Standard Treatment', 'type': 'DRUG', 'description': "The subjects will receive one of the standard anti-anginal therapies which included but not limited to aspirin, ACEI, lipid lowering statins and beta blockers according to the recommendation of guidelines. If the subject's condition permitted, they should take all these medicines. However, the dose, route, frequency and duration were determined by investigators according to subject's specific condition.", 'armGroupLabels': ['Standard treatment', 'Standard treatment plus nicorandil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'For Locations in', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono Co., Ltd., China', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}