Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01484912
Status:
COMPLETED
Last Update Posted:
2011-12-06
First Post:
2007-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase II Study of STA-2 in Patients With Chronic Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], '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': 'C037866', 'term': 'STA 2'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'justine@sinphar.com.tw', 'title': 'Justine Tang', 'organization': 'Sinphar Pharmaceutical Co., Ltd. Taiwan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'STA-2', 'description': 'STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.', 'otherNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo capsule, containing non-active ingredients.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.', 'otherNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Exercise Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STA-2', 'description': 'STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule, containing non-active ingredients.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}], 'classes': [{'categories': [{'measurements': [{'value': '450.39', 'spread': '106.7', 'groupId': 'OG000'}, {'value': '411.15', 'spread': '118.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'T-test was used to compare the change in total exercise time between the treatment groups. The change in total exercise time (△) was defined as the total exercise time at end-point visit minus the total exercise time at baseline. Let △T be the change in total exercise time for treatment group (STA-2) and △C be the change in total exercise time for control group (Placebo). The hypothesis testing for the superiority of STA-2 to Placebo was H0：△T-△C≦0 with H1：△T-△C﹥0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The superiority testing was conducted one sided with 0.025 significance level. If H0 was rejected one-sided 0.025 significance level, STA-2 was concluded to be statistically superior to Placebo.All hypothesis testing except for the primary efficacy endpoint was conducted two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline (visit 2) and week 6 (visit 5)', 'description': 'Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STA-2', 'description': 'STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule, containing non-active ingredients.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}], 'classes': [{'categories': [{'measurements': [{'value': '396.76', 'spread': '109', 'groupId': 'OG000'}, {'value': '341.69', 'spread': '138.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'All hypothesis testing was conducted with T-tests, two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline (visit 2) through week 6 (visit 5)', 'description': 'Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Consumption of Short-acting Nitrates', 'paramType': 'NUMBER', 'timeFrame': 'from baseline (visit 2) through week 6 (visit 5)', 'description': "The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits \\[V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)\\]according to patient's diary.", 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Rate-pressure Product', 'paramType': 'MEAN', 'timeFrame': 'baseline (visit 2) to week 6 (visit 5)', 'description': 'Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.', 'unitOfMeasure': 'rate', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pharmacological Parameters', 'paramType': 'MEAN', 'timeFrame': 'baseline (visit 2) to week 6 (visit 5)', 'description': 'The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.', 'unitOfMeasure': 'stress parameters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Consumption of Short-acting Nitrates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STA-2', 'description': 'STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule, containing non-active ingredients.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}], 'paramType': 'MEAN', 'timeFrame': "The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.", 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data was not available for analysis, because only two patients administered short-acting nitrates'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'STA-2', 'description': 'STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo capsule, containing non-active ingredients.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First Patient Enrolled: May-10-2007 Last Patient Completed: Jun-17-2008', 'preAssignmentDetails': 'Patients underwent one-week screening and washout period prior to randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'STA-2', 'description': 'STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo capsule, containing non-active ingredients.\n\nTwo capsules three times daily for 6 weeks, to be administered in a non-fasting state.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-01', 'studyFirstSubmitDate': '2007-05-09', 'resultsFirstSubmitDate': '2010-11-11', 'studyFirstSubmitQcDate': '2011-10-28', 'lastUpdatePostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-28', 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Exercise Time', 'timeFrame': 'baseline (visit 2) and week 6 (visit 5)', 'description': 'Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.'}], 'secondaryOutcomes': [{'measure': 'Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).', 'timeFrame': 'baseline (visit 2) through week 6 (visit 5)', 'description': 'Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.'}, {'measure': 'Change in Consumption of Short-acting Nitrates', 'timeFrame': 'from baseline (visit 2) through week 6 (visit 5)', 'description': "The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits \\[V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)\\]according to patient's diary."}, {'measure': 'Change in Rate-pressure Product', 'timeFrame': 'baseline (visit 2) to week 6 (visit 5)', 'description': 'Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.'}, {'measure': 'Change in Pharmacological Parameters', 'timeFrame': 'baseline (visit 2) to week 6 (visit 5)', 'description': 'The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.'}, {'measure': 'Consumption of Short-acting Nitrates', 'timeFrame': "The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Green tea polyphenols', 'Chronic Stable Angina'], 'conditions': ['Chronic Stable Angina']}, 'referencesModule': {'references': [{'pmid': '15946418', 'type': 'BACKGROUND', 'citation': 'Unno T, Tago M, Suzuki Y, Nozawa A, Sagesaka YM, Kakuda T, Egawa K, Kondo K. Effect of tea catechins on postprandial plasma lipid responses in human subjects. Br J Nutr. 2005 Apr;93(4):543-7. doi: 10.1079/bjn20041379.'}, {'pmid': '12824094', 'type': 'BACKGROUND', 'citation': 'Maron DJ, Lu GP, Cai NS, Wu ZG, Li YH, Chen H, Zhu JQ, Jin XJ, Wouters BC, Zhao J. Cholesterol-lowering effect of a theaflavin-enriched green tea extract: a randomized controlled trial. Arch Intern Med. 2003 Jun 23;163(12):1448-53. doi: 10.1001/archinte.163.12.1448.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.', 'detailedDescription': 'The primary objective of this study was to evaluate the efficacy of STA-2 in the management of chronic stable angina. The secondary objectives of this study were to evaluate the safety and pharmacological activities of STA-2 in the management of chronic stable angina. This was a multi-center, double-blind, randomized, parallel-group, placebo-controlled study of STA-2 in the management of chronic stable angina. The study period for each patient was approximately 7 weeks, during which the patient undergone one-week screening and washout period, followed by 6 weeks of treatment. Each patient was required to make a total of 5 visits. Primary Efficacy Endpoint: Change in total exercise time.\n\nAfter washout, patients who met the inclusion and exclusion criteria were randomly assigned either to the treatment or control group. The respective regimens were:\n\nTreatment group:\n\nSTA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules ter in die (t.i.d.=three times daily) for 6 weeks, to be administered in a non-fasting state.\n\nControl group:\n\nPlacebo 250 mg capsule, 2 capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Male or female aged \\> 20;\n2. Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening;\n3. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (Day -7);\n4. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by \\>20% in total exercise time;\n5. Female patient who was in the post-menopausal stage or of childbearing potential who:\n\n * used adequate contraception since last menstruation and no plan for conception during the study;\n * was non-lactating;\n * had negative pregnancy test (urine) within 14 days prior to the study;\n6. Able to provide written informed consent.\n\nExclusion criteria:\n\n1. Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;\n2. Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator;\n3. Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);\n4. Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;\n5. Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) \\> 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine \\> 3 mg/dL);\n6. Patients with severe gastrointestinal illness as judged by the investigator;\n7. Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).'}, 'identificationModule': {'nctId': 'NCT01484912', 'briefTitle': 'Phase II Study of STA-2 in Patients With Chronic Stable Angina', 'organization': {'class': 'OTHER', 'fullName': 'Sinphar Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina', 'orgStudyIdInfo': {'id': 'MCCD05014A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STA-2', 'description': 'STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.\n\nTwo capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.', 'interventionNames': ['Drug: STA-2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule, containing non-active ingredients.\n\nTwo capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'STA-2', 'type': 'DRUG', 'description': 'After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of STA-2 was:\n\nSTA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.', 'armGroupLabels': ['STA-2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of Placebo was:\n\nPlacebo 250 mg capsule, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tainan', 'state': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi Mei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital'}, {'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital'}], 'overallOfficials': [{'name': 'Chuen-Den Tseng, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinphar Pharmaceutical Co., Ltd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}