Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT00697203
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2008-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'C411602', 'term': 'dalcetrapib'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rblack@dalcorpharma.com', 'title': 'Ryan Black', 'organization': 'DalCor Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks', 'otherNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks', 'otherNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle Tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in HDL-C Level\\n', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'OG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17.18', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '31.42', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '36.45', 'spread': '2.24', 'groupId': 'OG002'}, {'value': '2.31', 'spread': '2.18', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in HDL-C Level\\n', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'OG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.58', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '11.90', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '13.92', 'spread': '0.86', 'groupId': 'OG002'}, {'value': '0.73', 'spread': '0.84', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change in mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'OG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '7.08', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '12.58', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '9.36', 'spread': '1.48', 'groupId': 'OG002'}, {'value': '1.35', 'spread': '1.45', 'groupId': 'OG003'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-5.95', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '4.11', 'groupId': 'OG001'}, {'value': '-5.01', 'spread': '4.02', 'groupId': 'OG002'}, {'value': '-4.25', 'spread': '3.93', 'groupId': 'OG003'}]}]}, {'title': 'HDL-C', 'categories': [{'measurements': [{'value': '17.18', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '31.42', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '36.45', 'spread': '2.24', 'groupId': 'OG002'}, {'value': '2.31', 'spread': '2.18', 'groupId': 'OG003'}]}]}, {'title': 'LDL-C', 'categories': [{'measurements': [{'value': '8.51', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '10.88', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '5.28', 'spread': '2.65', 'groupId': 'OG002'}, {'value': '3.84', 'spread': '2.59', 'groupId': 'OG003'}]}]}, {'title': 'HDL-2', 'categories': [{'measurements': [{'value': '52.10', 'spread': '8.19', 'groupId': 'OG000'}, {'value': '97.40', 'spread': '8.82', 'groupId': 'OG001'}, {'value': '121.2', 'spread': '8.49', 'groupId': 'OG002'}, {'value': '10.54', 'spread': '8.86', 'groupId': 'OG003'}]}]}, {'title': 'HDL-3', 'categories': [{'measurements': [{'value': '11.95', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '20.94', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '23.56', 'spread': '2.03', 'groupId': 'OG002'}, {'value': '0.68', 'spread': '2.12', 'groupId': 'OG003'}]}]}, {'title': 'ApoA1', 'categories': [{'measurements': [{'value': '7.03', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '13.60', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '14.90', 'spread': '1.40', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '1.46', 'groupId': 'OG003'}]}]}, {'title': 'ApoA2', 'categories': [{'measurements': [{'value': '3.82', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '8.07', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '8.36', 'spread': '1.28', 'groupId': 'OG002'}, {'value': '0.72', 'spread': '1.33', 'groupId': 'OG003'}]}]}, {'title': 'ApoB', 'categories': [{'measurements': [{'value': '2.66', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '-1.64', 'spread': '1.95', 'groupId': 'OG002'}, {'value': '-0.71', 'spread': '1.98', 'groupId': 'OG003'}]}]}, {'title': 'LpA1', 'categories': [{'measurements': [{'value': '15.06', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '22.68', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '24.76', 'spread': '3.40', 'groupId': 'OG002'}, {'value': '3.32', 'spread': '3.81', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'Percent change in mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change of Fasting Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'OG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.61', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '6.03', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '5.42', 'spread': '1.72', 'groupId': 'OG002'}, {'value': '3.00', 'spread': '1.70', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'Percent change in mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AEs, Lab Parameters, Vital Signs, ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'OG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}], 'timeFrame': 'Through 9 Months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'OG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}], 'classes': [{'title': 'HDL-C/LDL-C', 'categories': [{'measurements': [{'value': '-3.76', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '3.20', 'groupId': 'OG001'}, {'value': '-19.4', 'spread': '3.04', 'groupId': 'OG002'}, {'value': '3.09', 'spread': '2.95', 'groupId': 'OG003'}]}]}, {'title': 'ApoB/ApoA1', 'categories': [{'measurements': [{'value': '-4.97', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '-5.79', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '2.11', 'groupId': 'OG002'}, {'value': '-1.84', 'spread': '2.50', 'groupId': 'OG003'}]}]}, {'title': 'HDL-2/HDL-3', 'categories': [{'measurements': [{'value': '35.18', 'spread': '5.88', 'groupId': 'OG000'}, {'value': '63.40', 'spread': '6.33', 'groupId': 'OG001'}, {'value': '76.38', 'spread': '6.10', 'groupId': 'OG002'}, {'value': '8.89', 'spread': '6.37', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and at 12 Weeks', 'unitOfMeasure': 'Percent Change in Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'FG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'FG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\nDalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '292', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Dalcetrapib 300mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\ndalcetrapib: 300mg po daily for 12 weeks'}, {'id': 'BG001', 'title': 'Dalcetrapib 600mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\ndalcetrapib: 600mg po daily for 12 weeks'}, {'id': 'BG002', 'title': 'Dalcetrapib 900mg', 'description': 'Pravastatin: 40mg po daily for 12 weeks\n\ndalcetrapib: 900mg po daily for 12 weeks'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo: po daily for 12 weeks\n\nPravastatin: 40mg po daily for 12 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '10.24', 'groupId': 'BG000'}, {'value': '57.1', 'spread': '10.53', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '10.52', 'groupId': 'BG002'}, {'value': '57.2', 'spread': '10.87', 'groupId': 'BG003'}, {'value': '56.7', 'spread': '10.49', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '234', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2008-06-11', 'resultsFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-13', 'studyFirstPostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in HDL-C Level\\n', 'timeFrame': 'Week 12'}, {'measure': 'Percent Change From Baseline in HDL-C Level\\n', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI', 'timeFrame': '12 weeks'}, {'measure': 'Percent Change of Fasting Glucose Level', 'timeFrame': '12 weeks'}, {'measure': 'AEs, Lab Parameters, Vital Signs, ECG', 'timeFrame': 'Through 9 Months'}, {'measure': 'Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB', 'timeFrame': 'Baseline and at 12 Weeks'}]}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients 18-75 years of age;\n* dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.\n\nExclusion Criteria:\n\n* women who are pregnant, breastfeeding, or of child-bearing potential;\n* morbid obesity;\n* uncontrolled hypertension;\n* poorly controlled or insulin-treated diabetes;\n* high creatinine levels or history of statin-associated myopathy.'}, 'identificationModule': {'nctId': 'NCT00697203', 'briefTitle': 'A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels', 'orgStudyIdInfo': {'id': 'NC18589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dalcetrapib 300mg', 'interventionNames': ['Drug: Pravastatin', 'Drug: Dalcetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Dalcetrapib 600mg', 'interventionNames': ['Drug: Pravastatin', 'Drug: Dalcetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Dalcetrapib 900mg', 'interventionNames': ['Drug: Pravastatin', 'Drug: Dalcetrapib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo', 'Drug: Pravastatin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'po daily for 12 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Pravastatin', 'type': 'DRUG', 'description': '40mg po daily for 12 weeks', 'armGroupLabels': ['Dalcetrapib 300mg', 'Dalcetrapib 600mg', 'Dalcetrapib 900mg', 'Placebo']}, {'name': 'Dalcetrapib', 'type': 'DRUG', 'description': '300mg po daily for 12 weeks', 'armGroupLabels': ['Dalcetrapib 300mg']}, {'name': 'Dalcetrapib', 'type': 'DRUG', 'description': '600mg po daily for 12 weeks', 'armGroupLabels': ['Dalcetrapib 600mg']}, {'name': 'Dalcetrapib', 'type': 'DRUG', 'description': '900mg po daily for 12 weeks', 'armGroupLabels': ['Dalcetrapib 900mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '19713', 'city': 'Newark', 'state': 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