Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT00768560
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2008-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Sponsor:
Organization:
Raw JSON
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(Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning', 'otherNumAtRisk': 35, 'otherNumAffected': 5, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening', 'otherNumAtRisk': 34, 'otherNumAffected': 7, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning', 'otherNumAtRisk': 34, 'otherNumAffected': 5, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lipid metabolism disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Sitting Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning'}, {'id': 'OG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening'}, {'id': 'OG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-10.19', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-19.88', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-10.13', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-4.30', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-8.28', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '-4.98', 'spread': '0.65', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-9.69', 'ciLowerLimit': '-12.62', 'ciUpperLimit': '-6.77', 'estimateComment': '40 mg BID minus 40 mg OD', 'groupDescription': 'The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.06', 'ciLowerLimit': '-2.87', 'ciUpperLimit': '2.98', 'estimateComment': '80 mg OD minus 40 mg OD', 'groupDescription': 'The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '9.75', 'ciLowerLimit': '6.83', 'ciUpperLimit': '12.67', 'estimateComment': '80 mg OD minus 40 mg BID', 'groupDescription': 'The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-3.97', 'ciLowerLimit': '-5.50', 'ciUpperLimit': '-2.44', 'estimateComment': '40 mg BID minus 40 mg OD', 'groupDescription': 'The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference 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'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and after 2 weeks treatment', 'description': 'Changes of sitting SBP and DBP (trough values) from baseline (ie \\[trough BP at the end of each period during the double-blind treatment period\\] minus \\[trough BP at the end of the baseline treatment period\\])', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.'}, {'type': 'SECONDARY', 'title': 'Differences of Systolic Blood Pressure Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning'}, {'id': 'OG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening'}, {'id': 'OG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning'}], 'classes': [{'title': 'At 0-hour post-dose', 'categories': [{'measurements': [{'value': '-11.35', 'spread': '15.75', 'groupId': 'OG000'}, {'value': '-21.24', 'spread': '11.56', 'groupId': 'OG001'}, {'value': '-9.91', 'spread': '10.58', 'groupId': 'OG002'}]}]}, {'title': 'At 2-hour post-dose', 'categories': [{'measurements': [{'value': '-4.91', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '-8.65', 'spread': '11.19', 'groupId': 'OG001'}, {'value': '-11.97', 'spread': '10.15', 'groupId': 'OG002'}]}]}, {'title': 'At 4-hour post-dose', 'categories': [{'measurements': [{'value': '-6.18', 'spread': '12.05', 'groupId': 'OG000'}, {'value': '-5.76', 'spread': '11.25', 'groupId': 'OG001'}, {'value': '-7.85', 'spread': '10.02', 'groupId': 'OG002'}]}]}, {'title': 'At 6-hour post-dose', 'categories': [{'measurements': [{'value': '-6.56', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '-4.94', 'spread': '9.31', 'groupId': 'OG001'}, {'value': '-7.26', 'spread': '8.40', 'groupId': 'OG002'}]}]}, {'title': 'At 8-hour post-dose', 'categories': [{'measurements': [{'value': '-7.88', 'spread': '11.53', 'groupId': 'OG000'}, {'value': '-6.97', 'spread': '10.23', 'groupId': 'OG001'}, {'value': '-7.88', 'spread': '10.68', 'groupId': 'OG002'}]}]}, {'title': 'At 10-hour post-dose', 'categories': [{'measurements': [{'value': '-4.79', 'spread': '10.60', 'groupId': 'OG000'}, {'value': '-4.03', 'spread': '10.64', 'groupId': 'OG001'}, {'value': '-6.56', 'spread': '9.41', 'groupId': 'OG002'}]}]}, {'title': 'At 12-hour post-dose', 'categories': [{'measurements': [{'value': '-5.59', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '-4.38', 'spread': '9.31', 'groupId': 'OG001'}, {'value': '-6.00', 'spread': '9.98', 'groupId': 'OG002'}]}]}, {'title': 'At 24-hour post-dose', 'categories': [{'measurements': [{'value': '-8.97', 'spread': '12.79', 'groupId': 'OG000'}, {'value': '-18.38', 'spread': '8.34', 'groupId': 'OG001'}, {'value': '-10.21', 'spread': '10.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 2 weeks treatment', 'description': 'Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects valid for efficacy analysis'}, {'type': 'SECONDARY', 'title': 'Differences of Diastolic Blood Pressure Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning'}, {'id': 'OG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening'}, {'id': 'OG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning'}], 'classes': [{'title': 'At 0-hour post-dose', 'categories': [{'measurements': [{'value': '-3.82', 'spread': '6.40', 'groupId': 'OG000'}, {'value': '-8.12', 'spread': '6.24', 'groupId': 'OG001'}, {'value': '-4.18', 'spread': '5.54', 'groupId': 'OG002'}]}]}, {'title': 'At 2-hour post-dose', 'categories': [{'measurements': [{'value': '-4.15', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '-5.47', 'spread': '7.01', 'groupId': 'OG001'}, {'value': '-7.18', 'spread': '5.89', 'groupId': 'OG002'}]}]}, {'title': 'At 4-hour post dose', 'categories': [{'measurements': [{'value': '-3.44', 'spread': '7.47', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '8.11', 'groupId': 'OG001'}, {'value': '-3.68', 'spread': '6.33', 'groupId': 'OG002'}]}]}, {'title': 'At 6-hour post-dose', 'categories': [{'measurements': [{'value': '-5.56', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '7.20', 'groupId': 'OG001'}, {'value': '-3.85', 'spread': '5.94', 'groupId': 'OG002'}]}]}, {'title': 'At 8-hour post dose', 'categories': [{'measurements': [{'value': '-3.09', 'spread': '6.13', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '6.26', 'groupId': 'OG001'}, {'value': '-4.74', 'spread': '6.30', 'groupId': 'OG002'}]}]}, {'title': 'At 10-hour post-dose', 'categories': [{'measurements': [{'value': '-2.24', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '-1.74', 'spread': '6.42', 'groupId': 'OG001'}, {'value': '-3.82', 'spread': '7.26', 'groupId': 'OG002'}]}]}, {'title': 'At 12-hour post-dose', 'categories': [{'measurements': [{'value': '-2.47', 'spread': '6.59', 'groupId': 'OG000'}, {'value': '-2.15', 'spread': '7.30', 'groupId': 'OG001'}, {'value': '-3.15', 'spread': '6.97', 'groupId': 'OG002'}]}]}, {'title': 'At 24-hour post dose', 'categories': [{'measurements': [{'value': '-5.00', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '-8.47', 'spread': '5.39', 'groupId': 'OG001'}, {'value': '-5.82', 'spread': '8.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 2 weeks treatment', 'description': 'Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects valid for efficacy analysis'}, {'type': 'SECONDARY', 'title': 'Target Blood Pressure Achievement in Elderly (≥65)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning'}, {'id': 'OG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening'}, {'id': 'OG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 2 weeks treatment', 'description': 'Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP \\<140 mm Hg and DBP \\<90 mm Hg', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects valid for efficacy analysis'}, {'type': 'SECONDARY', 'title': 'Target Blood Pressure Achievement in Non-elderly (<65)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning'}, {'id': 'OG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening'}, {'id': 'OG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 2 weeks treatment', 'description': 'Non-elderly subjects (\\<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP \\<130 mm Hg and DBP \\<85 mm Hg', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects valid for efficacy analysis'}, {'type': 'SECONDARY', 'title': 'Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning'}, {'id': 'OG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening'}, {'id': 'OG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 2 weeks treatment', 'description': 'Subjects with diabetes mellitus or chronic renal disorders and target BP SBP \\<130 mm Hg and DBP \\<80 mm Hg', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects valid for efficacy analysis'}, {'type': 'SECONDARY', 'title': 'Target Blood Pressure Achievement in All Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning'}, {'id': 'OG001', 'title': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening'}, {'id': 'OG002', 'title': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 2 weeks treatment', 'description': 'Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP \\<140 mm Hg and DBP \\<90 mm Hg. Subjects (\\<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP \\<130 mm Hg and DBP \\<85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP \\<130 mm Hg and DBP \\<80 mm Hg.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects valid for efficacy analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each'}, {'id': 'FG001', 'title': 'Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each'}, {'id': 'FG002', 'title': 'Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each'}, {'id': 'FG003', 'title': 'Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each'}, {'id': 'FG004', 'title': 'Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each'}, {'id': 'FG005', 'title': 'Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each'}], 'periods': [{'title': 'Intervention Set 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '3-period/treatment crossover', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': '3-period/treatment crossover', 'groupId': 'FG001', 'numSubjects': '6'}, {'comment': '3-period/treatment crossover', 'groupId': 'FG002', 'numSubjects': '6'}, {'comment': '3-period/treatment crossover', 'groupId': 'FG003', 'numSubjects': '6'}, {'comment': '3-period/treatment crossover', 'groupId': 'FG004', 'numSubjects': '6'}, {'comment': '3-period/treatment crossover', 'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Subjects Received Treatment', 'achievements': [{'comment': '40 mg OD for 2 weeks', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': '40 mg OD for 2 weeks', 'groupId': 'FG001', 'numSubjects': '6'}, {'comment': '40 mg twice daily (BID) for 2 weeks', 'groupId': 'FG002', 'numSubjects': '6'}, {'comment': '40 mg BID for 2 weeks', 'groupId': 'FG003', 'numSubjects': '6'}, {'comment': '80 mg OD for 2 weeks', 'groupId': 'FG004', 'numSubjects': '6'}, {'comment': '80 mg OD for 2 weeks', 'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Intervention Set 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '40 mg BID for 2 weeks', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': '80 mg OD for 2 weeks', 'groupId': 'FG001', 'numSubjects': '5'}, {'comment': '80 mg OD for 2 weeks', 'groupId': 'FG002', 'numSubjects': '6'}, {'comment': '40 mg OD for 2 weeks', 'groupId': 'FG003', 'numSubjects': '6'}, {'comment': '40 mg OD for 2 weeks', 'groupId': 'FG004', 'numSubjects': '6'}, {'comment': '40 mg BID for 2 weeks', 'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Intervention Set 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '80 mg OD for 2 weeks', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': '40 mg BID for 2 weeks', 'groupId': 'FG001', 'numSubjects': '5'}, {'comment': '40 mg OD for 2 weeks', 'groupId': 'FG002', 'numSubjects': '6'}, {'comment': '80 mg OD for 2 weeks', 'groupId': 'FG003', 'numSubjects': '6'}, {'comment': '40 mg BID for 2 weeks', 'groupId': 'FG004', 'numSubjects': '6'}, {'comment': '40 mg OD for 2 weeks', 'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '47 subjects were recruited from 30 Jan 2008 to 11 May 2008 by 3 centers in Japan.', 'preAssignmentDetails': 'After a 4-week baseline treatment with Adalat controlled release (CR) 40 mg once daily (OD), 35 subjects were randomized to double-blind treatment and were included in the safety analysis. 34 subjects were included in the analysis of pharmacokinetics, efficacy and demographic data. 1 subject discontinued the study in Period 1 due to adverse event.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each'}, {'id': 'BG001', 'title': 'Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each'}, {'id': 'BG002', 'title': 'Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each'}, {'id': 'BG003', 'title': 'Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each'}, {'id': 'BG004', 'title': 'Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each'}, {'id': 'BG005', 'title': 'Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '68'}, {'value': '63.6', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '73'}, {'value': '59.7', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '65'}, {'value': '64.3', 'groupId': 'BG003', 'lowerLimit': '60', 'upperLimit': '70'}, {'value': '58.2', 'groupId': 'BG004', 'lowerLimit': '37', 'upperLimit': '67'}, {'value': '59.7', 'groupId': 'BG005', 'lowerLimit': '56', 'upperLimit': '68'}, {'value': '61.1', 'groupId': 'BG006', 'lowerLimit': '37', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Blood Pressure (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) at Baseline', 'classes': [{'title': 'SBP at baseline', 'categories': [{'measurements': [{'value': '150.00', 'spread': '7.91', 'groupId': 'BG000'}, {'value': '161.00', 'spread': '16.67', 'groupId': 'BG001'}, {'value': '156.33', 'spread': '11.18', 'groupId': 'BG002'}, {'value': '155.83', 'spread': '10.96', 'groupId': 'BG003'}, {'value': '156.33', 'spread': '14.79', 'groupId': 'BG004'}, {'value': '154.83', 'spread': '13.53', 'groupId': 'BG005'}, {'value': '155.89', 'spread': '12.38', 'groupId': 'BG006'}]}]}, {'title': 'DBP at baseline', 'categories': [{'measurements': [{'value': '94.40', 'spread': '4.98', 'groupId': 'BG000'}, {'value': '95.00', 'spread': '6.60', 'groupId': 'BG001'}, {'value': '98.00', 'spread': '6.45', 'groupId': 'BG002'}, {'value': '91.00', 'spread': '7.07', 'groupId': 'BG003'}, {'value': '92.50', 'spread': '3.45', 'groupId': 'BG004'}, {'value': '89.83', 'spread': '7.68', 'groupId': 'BG005'}, {'value': '93.43', 'spread': '6.40', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Blood pressure (BP) before the start of baseline treatment. Subjects valid for safety analysis', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate (HR) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '64.20', 'spread': '6.18', 'groupId': 'BG000'}, {'value': '72.67', 'spread': '13.95', 'groupId': 'BG001'}, {'value': '79.00', 'spread': '10.81', 'groupId': 'BG002'}, {'value': '70.83', 'spread': '5.42', 'groupId': 'BG003'}, {'value': '68.50', 'spread': '7.87', 'groupId': 'BG004'}, {'value': '79.50', 'spread': '17.84', 'groupId': 'BG005'}, {'value': '72.69', 'spread': '11.83', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Heart rate (HR) before the start of baseline treatment. Subjects valid for safety analysis', 'unitOfMeasure': 'beats / min', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2008-10-07', 'resultsFirstSubmitDate': '2009-09-28', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-07', 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Sitting Blood Pressure', 'timeFrame': 'Baseline and after 2 weeks treatment', 'description': 'Changes of sitting SBP and DBP (trough values) from baseline (ie \\[trough BP at the end of each period during the double-blind treatment period\\] minus \\[trough BP at the end of the baseline treatment period\\])'}], 'secondaryOutcomes': [{'measure': 'Differences of Systolic Blood Pressure Profile', 'timeFrame': 'Baseline and after 2 weeks treatment', 'description': 'Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)'}, {'measure': 'Differences of Diastolic Blood Pressure Profile', 'timeFrame': 'Baseline and after 2 weeks treatment', 'description': 'Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)'}, {'measure': 'Target Blood Pressure Achievement in Elderly (≥65)', 'timeFrame': 'After 2 weeks treatment', 'description': 'Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP \\<140 mm Hg and DBP \\<90 mm Hg'}, {'measure': 'Target Blood Pressure Achievement in Non-elderly (<65)', 'timeFrame': 'After 2 weeks treatment', 'description': 'Non-elderly subjects (\\<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP \\<130 mm Hg and DBP \\<85 mm Hg'}, {'measure': 'Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder', 'timeFrame': 'After 2 weeks treatment', 'description': 'Subjects with diabetes mellitus or chronic renal disorders and target BP SBP \\<130 mm Hg and DBP \\<80 mm Hg'}, {'measure': 'Target Blood Pressure Achievement in All Subjects', 'timeFrame': 'After 2 weeks treatment', 'description': 'Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP \\<140 mm Hg and DBP \\<90 mm Hg. Subjects (\\<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP \\<130 mm Hg and DBP \\<85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP \\<130 mm Hg and DBP \\<80 mm Hg.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).', 'detailedDescription': 'Issues on safety are addressed in the Adverse Event section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female\n* 20 years or older and less than 75 years\n* Outpatient\n* Untreated or treated patients with antihypertensive agents whose blood pressure (BP) in sitting position at entry (Visit 1) is as follows.\n\n * Untreated patients: systolic blood pressure (SBP) \\>= 160mmHg or diastolic blood pressure (DBP) \\>= 100mmHg\n * Treated patients: SBP \\>= 140mmHg or DBP \\>= 90mmHg (at trough)\n\nExclusion Criteria:\n\n* Patients whose BP during baseline treatment period is: SBP\\>=200mmHg or DBP\\>=120mmHg.\n* Patients with secondary hypertension or hypertensive emergency.\n* Patients with cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack (TIA), myocardial infarction or unstable angina), or with history of these within 6 months prior to the study.\n* Patients with intracranial or subarachnoid hemorrhage, or with history of these within 6 months prior to the study.\n* Patients with server hematopoietic dysfunction (acute/chronic leukemia, myeloma, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or with history of these.'}, 'identificationModule': {'nctId': 'NCT00768560', 'briefTitle': 'Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.', 'orgStudyIdInfo': {'id': '13012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nifedipine (Adalat CR, BAYA1040) 40 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning', 'interventionNames': ['Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD']}, {'type': 'EXPERIMENTAL', 'label': 'Nifedipine (Adalat CR, BAYA1040) 40 mg BID', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening', 'interventionNames': ['Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'Nifedipine (Adalat CR, BAYA1040) 80 mg OD', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning', 'interventionNames': ['Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD']}], 'interventions': [{'name': 'Nifedipine (Adalat CR, BAYA1040) 80mg OD', 'type': 'DRUG', 'description': 'Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning', 'armGroupLabels': ['Nifedipine (Adalat CR, BAYA1040) 80 mg OD']}, {'name': 'Nifedipine (Adalat CR, BAYA1040) 40mg BID', 'type': 'DRUG', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening', 'armGroupLabels': ['Nifedipine (Adalat CR, BAYA1040) 40 mg BID']}, {'name': 'Nifedipine (Adalat CR, BAYA1040) 40mg OD', 'type': 'DRUG', 'description': 'Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning', 'armGroupLabels': ['Nifedipine (Adalat CR, BAYA1040) 40 mg OD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '982-0032', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '565-0853', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '343-0827', 'city': 'Koshigaya', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}