Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-02 @ 4:35 AM
Study NCT ID:
NCT01788358
Status:
COMPLETED
Last Update Posted:
2017-10-24
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'Bayer HealthCare AG'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS', 'description': 'One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).', 'otherNumAtRisk': 508, 'otherNumAffected': 279, 'seriousNumAtRisk': 508, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 80, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 239, 'numAffected': 150}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 55, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 60, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'All TEAEs', 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}]}]}, {'title': 'Drug-related TEAEs', 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of first study drug administration up to Week 28', 'description': 'An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'Oedema (mild)', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Oedema (moderate)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Oedema (severe)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Headache (mild)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Headache (moderate)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Flushing (mild)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Symptomatic hypotension (mild)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of first study drug administration up to Week 28', 'description': 'An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'All TEAEs', 'categories': [{'measurements': [{'value': '404', 'groupId': 'OG000'}]}]}, {'title': 'Drug-related TEAEs', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of first study drug administration up to Week 52/EOS', 'description': 'An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'Oedema (mild)', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'Oedema (moderate)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Oedema(severe)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Headache (mild)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Headache (moderate)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Flushing (mild)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Symptomatic hypotension (mild)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of study treatment up to Week 52/EOS', 'description': 'An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Clinically Relevant Changes in Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 52/EOS', 'description': 'Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '170.7', 'spread': '8.9', 'groupId': 'OG000', 'lowerLimit': '8.9'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '-30.4', 'spread': '17.7', 'groupId': 'OG000', 'lowerLimit': '17.7'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '-30.1', 'spread': '18.4', 'groupId': 'OG000', 'lowerLimit': '18.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Weeks 28 and 52', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention-to-treat analysis set (mITT): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '95.6', 'spread': '10.4', 'groupId': 'OG000', 'lowerLimit': '10.4'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '-12.7', 'spread': '10.6', 'groupId': 'OG000', 'lowerLimit': '10.6'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '-12.8', 'spread': '10.7', 'groupId': 'OG000', 'lowerLimit': '10.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Weeks 28 and 52', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Control Rate at Weeks 28 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 28 and 52', 'description': 'Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (\\<) 140/90 mmHg.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Response Rate at Weeks 28 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 28 and 52', 'description': 'Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of \\<140 mmHg or a reduction of MSSBP of more than (\\>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of \\<90 mmHg or a reduction of MSDBP of \\>10 mmHg from baseline value).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '508'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '508'}]}, {'type': 'Completed Week 28', 'achievements': [{'groupId': 'FG000', 'numSubjects': '417'}]}, {'type': 'Entered Extension to Week 52', 'achievements': [{'comment': 'Only the first 200 subjects who completed Week 28 visit, continued treatment up to 52 weeks.', 'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'Completed Week 52', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '217 subjects completed the study at Week 28 while the remaining 193 subjects completed at Week 52', 'groupId': 'FG000', 'numSubjects': '410'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Logistical difficulties', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}]}]}], 'recruitmentDetails': 'The study was conducted at 70 study centers between 14 February 2013 (first subject first visit) and 1 May 2014 (last subject last visit).', 'preAssignmentDetails': 'Of 753 subjects screened, 245 subjects were not enrolled, due to screen failure for 215 subjects, consent withdrawal by 23 subjects, protocol violation by 5 subjects, 1 subject was lost to follow-up and recruitment stopped for 1 subject. Remaining 508 subjects were enrolled and received at least 1 treatment with study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '322', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '170.7', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '95.6', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2015-06-04', 'completionDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2013-02-07', 'dispFirstSubmitQcDate': '2015-06-04', 'resultsFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2013-02-07', 'dispFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-21', 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28', 'timeFrame': 'From the time of first study drug administration up to Week 28', 'description': 'An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.'}, {'measure': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28', 'timeFrame': 'From the time of first study drug administration up to Week 28', 'description': 'An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.'}, {'measure': 'Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)', 'timeFrame': 'From the time of first study drug administration up to Week 52/EOS', 'description': 'An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.'}, {'measure': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)', 'timeFrame': 'From the time of study treatment up to Week 52/EOS', 'description': 'An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Clinically Relevant Changes in Laboratory Parameters', 'timeFrame': 'Baseline (Week 0) up to Week 52/EOS', 'description': 'Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.'}, {'measure': 'Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52', 'timeFrame': 'Baseline (Week 0), Weeks 28 and 52'}, {'measure': 'Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52', 'timeFrame': 'Baseline (Week 0), Weeks 28 and 52'}, {'measure': 'Blood Pressure Control Rate at Weeks 28 and 52', 'timeFrame': 'Weeks 28 and 52', 'description': 'Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (\\<) 140/90 mmHg.'}, {'measure': 'Blood Pressure Response Rate at Weeks 28 and 52', 'timeFrame': 'Weeks 28 and 52', 'description': 'Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of \\<140 mmHg or a reduction of MSSBP of more than (\\>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of \\<90 mmHg or a reduction of MSDBP of \\>10 mmHg from baseline value).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug combination', 'Nifedipine GITS', 'Candesartan Cilexetil', 'Hypertension', 'Combination therapy'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.\n\nPatients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total).\n\nSubjects who do not tolerate an increased dose will be treated at their highest tolerable dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of \\>/= 160 mmHg and \\< 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP \\>/= 160 mmHg and \\<200 mmHg after wash out.\n* Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active\n\nExclusion Criteria:\n\n* Mean seated systolic blood pressure \\>/= 200 mmHg and/or mean seated diastolic blood pressure \\>/= 120 mm/Hg\n* Mean seated diastolic blood pressure \\< 60 mm/Hg\n* Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0\n* Any history of hypertensive emergency\n* Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.\n* Cerebrovascular ischemic event (stroke, transient ischemic attack \\[TIA\\])within the previous 12 months\n* History of intracerebral hemorrhage or subarachnoid hemorrhage\n* History of hypertensive retinopathy - known Keith-Wagener Grade III or IV\n* Any history of heart failure, New York Heart Association (NYHA) classification III or IV\n* Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0\n* Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.\n* Hyperkalemia: potassium above the upper limit of normal in the laboratory range'}, 'identificationModule': {'nctId': 'NCT01788358', 'briefTitle': 'Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects With Moderate to Severe Essential Hypertension', 'orgStudyIdInfo': {'id': '14801'}, 'secondaryIdInfos': [{'id': '2012-004515-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)', 'description': 'Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \\[mg\\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).', 'interventionNames': ['Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)']}], 'interventions': [{'name': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)', 'type': 'DRUG', 'description': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily', 'armGroupLabels': ['Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)']}, {'name': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)', 'type': 'DRUG', 'description': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily', 'armGroupLabels': ['Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)']}, {'name': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)', 'type': 'DRUG', 'description': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily', 'armGroupLabels': ['Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)']}, {'name': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)', 'type': 'DRUG', 'description': 'Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily', 'armGroupLabels': ['Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '06460', 'city': 'Milford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.22232, 'lon': -73.0565}}, {'zip': '33114-4192', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33083', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04240', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}, {'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28150', 'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '45224', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37825', 'city': 'New Tazewell', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.44258, 'lon': -83.59963}}, {'zip': '77701', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}, {'zip': '9310', 'city': 'Moorsel', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'geoPoint': {'lat': 50.94743, 'lon': 4.09825}}, {'zip': '9230', 'city': 'Wetteren', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'geoPoint': {'lat': 51.00526, 'lon': 3.88341}}, {'zip': '1820', 'city': 'Steenokkerzeel', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'geoPoint': {'lat': 50.91851, 'lon': 4.50989}}, {'zip': '2100', 'city': 'Deurne', 'country': 'Belgium', 'geoPoint': {'lat': 51.22134, 'lon': 4.46595}}, {'zip': '3545', 'city': 'Ham', 'country': 'Belgium', 'geoPoint': {'lat': 50.94066, 'lon': 3.45852}}, {'zip': 'V5G 1T4', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'zip': 'V3A 4H9', 'city': 'Langley', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.10107, 'lon': -122.65883}}, {'zip': 'V5Z 1K3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L7M 4Y1', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'M8V 3X8', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'N5W 6A2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'L0M 1S0', 'city': 'Stayner', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 44.41833, 'lon': -80.09598}}, {'zip': 'M4S 1Y2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N4S 4G3', 'city': 'Woodstock', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.13339, 'lon': -80.7497}}, {'zip': 'H9R 3J1', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1W 1S2', 'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada'}, {'zip': '60313', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '44787', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '02826', 'city': 'Görlitz', 'state': 'Saxony', 'country': 'Germany', 'geoPoint': {'lat': 51.15518, 'lon': 14.98853}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '39104', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '12627', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dresden', 'country': 'Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '81-384', 'city': 'Gdynia', 'country': 'Poland', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '40-040', 'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '01-192', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-088', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': 'RG2 0TG', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'S40 4AA', 'city': 'Chesterfield', 'state': 'Derbyshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.25, 'lon': -1.41667}}, {'zip': 'FY3 7EN', 'city': 'Blackpool', 'state': 'Lancashire', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BA3 2UH', 'city': 'Bath', 'state': 'Somerset', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'IP30 9QU', 'city': 'Bury Saint Edmonds', 'state': 'Suffolk', 'country': 'United Kingdom'}, {'zip': 'CV6 4DD', 'city': 'Coventry', 'state': 'Warwickshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'B15 2SQ', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CF14 5GJ', 'city': 'Cardiff', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'PR7 7NA', 'city': 'Chorley', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.65, 'lon': -2.61667}}, {'zip': 'G20 OSP', 'city': 'Glasgow', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'L22 0LG', 'city': 'Liverpool', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'M15 6SX', 'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}