Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-04 @ 8:45 PM
Study NCT ID:
NCT01474434
Status:
TERMINATED
Last Update Posted:
2016-04-14
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of LCQ908 on Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594809', 'term': 'pradigastat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. Part B was not conducted. Not all the planned assessments were completed due to the termination'}}, 'adverseEventsModule': {'description': 'The safety analysis set included all patients who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.', 'otherNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period', 'otherNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.', 'otherNumAtRisk': 24, 'otherNumAffected': 22, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A, Cohort 2: Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period', 'otherNumAtRisk': 24, 'otherNumAffected': 13, 'seriousNumAtRisk': 24, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fracture pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, and on day 5 of each of the two treatment periods', 'description': 'MPRi (myocardial perfusion reserve index) is a measure of coronary microvascular function. Myocardial perfusion scans using 0.05 mmol/kg of gadolinium contrast were acquired at rest and under stress (pharmacological stress induced with adenosine 140 μg/kg/min for three minutes). An independent central reader performed the cardiac image analysis of all time points including the calculation of the myocardial perfusion reserve index from the ratio of the global stress myocardial blood flow divided by the resting blood flow values. Higher/increased index indicates improved flow/better outcome. This primary endpoint was only for Part A, Cohort 1 patients.', 'unitOfMeasure': 'myocardial perfusion reserve index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set - Patients who took \\> 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of MPRi at both baseline and post-treatment visits. Patients who had no baseline or post-treatment MPRi data in 1 of 2 periods were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Total Exercise Duration (Part A, Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.52', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and on day 5 of each of the two treatment periods', 'description': 'Total exercise duration was the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue. This primary endpoint was only for Part A, Cohort 1 patients.', 'unitOfMeasure': 'minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set- Patients who took \\> 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of total exercise duration at both baseline and post-treatment visits. Patients who had no baseline or post-treatment exercise duration data in 1 of 2 periods were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Time to Onset of Angina (Part A, Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'timeFrame': 'Baseline and on day 5 of each of the two treatment periods', 'description': 'Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the patient and recorded by the performing investigator.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .'}, {'type': 'PRIMARY', 'title': 'Time to Onset of Exercise-induced Ischemia(Part A, Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'timeFrame': 'Baseline and on day 5 of each of the two treatment periods', 'description': 'Exercise-induced ischemia was defined as the new development of horizontal or down-sloping ST-segment depression (≥ 1mm at 60 milliseconds after the J point) versus baseline tracings.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .'}, {'type': 'PRIMARY', 'title': 'Aortic Plaque Inflammation (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Pradigastat (LCQ908)'}, {'id': 'OG001', 'title': 'Part B: Placebo'}], 'timeFrame': 'Baseline and on treatment day 85 +/- 3 days', 'description': 'This endpoint was palnned for analysis on Part B patients which was never started becasue study got terminated on Part A interim analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis after patients completed Part A. Part B of the study was never started.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (Part A, Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'classes': [{'title': 'Any Adverse Events', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 40 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (Part A, Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 2: Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'classes': [{'title': 'Any Adverse Events', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 40 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Postprandial Triglycerides (Part A, Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'classes': [{'title': 'Day 5 Hr 0', 'categories': [{'measurements': [{'value': '1.15', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 5 Hr 2', 'categories': [{'measurements': [{'value': '1.21', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 5 Hr 4', 'categories': [{'measurements': [{'value': '1.29', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5', 'description': 'For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour(before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.'}, {'type': 'SECONDARY', 'title': 'Postprandial Triglycerides (Part A, Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 2: Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'classes': [{'title': 'Day 5 Hr 0', 'categories': [{'measurements': [{'value': '1.16', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 5 Hr 2', 'categories': [{'measurements': [{'value': '1.15', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 5 Hr 4', 'categories': [{'measurements': [{'value': '1.14', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5', 'description': 'For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour (before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Pradigastat (LCQ908): Plasma Concentration (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}, {'id': 'OG002', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.'}, {'id': 'OG003', 'title': 'Part A, Cohort 2: Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'timeFrame': 'Part A: Day 4 and day 5 of each treatment period', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.'}, {'type': 'SECONDARY', 'title': 'Other Related Lipid Parameters (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}, {'id': 'OG002', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.'}, {'id': 'OG003', 'title': 'Part A, Cohort 2: Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'timeFrame': 'Baseline, day 4 and day 5 of each treatment period', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.'}, {'type': 'SECONDARY', 'title': 'Interleukin-6 (IL-6) Level (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}, {'id': 'OG002', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.'}, {'id': 'OG003', 'title': 'Part A, Cohort 2: Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'timeFrame': 'Baseline, day 4 and day 5, of each treatment period', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein (CRP) Level (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.'}, {'id': 'OG001', 'title': 'Part A, Cohort 1: Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}, {'id': 'OG002', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.'}, {'id': 'OG003', 'title': 'Part A, Cohort 2: Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period'}], 'timeFrame': 'Baseline, day 4 and day 5, of each treatment period', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.'}, {'type': 'SECONDARY', 'title': 'Adiponectin Level ( Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Pradigastat (LCQ908)'}, {'id': 'OG001', 'title': 'Part B: Placebo'}], 'timeFrame': 'Part B; Baseline, day 15, day 43 and day 85', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated based on the interim analysis on Part A, cohort 1 after patients completed Part A. Part B of the study was not commenced.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment'}, {'id': 'FG001', 'title': 'Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days'}, {'id': 'FG002', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment'}, {'id': 'FG003', 'title': 'Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days'}], 'periods': [{'title': 'Treatment Period 1 (5 Days [Day 1 - 5])', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2(5 Days[Day 36 - 40])', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study was terminated upon Part A interim analysis. Total 41 patients randomized to Part A i.e.17 patients in cohort 1 and 24 patients in Cohort 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment'}, {'id': 'BG001', 'title': 'Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)', 'description': 'Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days'}, {'id': 'BG002', 'title': 'Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment'}, {'id': 'BG003', 'title': 'Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)', 'description': 'Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '6.67', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '8.79', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '9.79', 'groupId': 'BG002'}, {'value': '56.1', 'spread': '8.85', 'groupId': 'BG003'}, {'value': '57.5', 'spread': '8.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set included all patients who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'The study was terminated based on interim analysis. See detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2011-11-09', 'resultsFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-16', 'studyFirstPostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)', 'timeFrame': 'Baseline, and on day 5 of each of the two treatment periods', 'description': 'MPRi (myocardial perfusion reserve index) is a measure of coronary microvascular function. Myocardial perfusion scans using 0.05 mmol/kg of gadolinium contrast were acquired at rest and under stress (pharmacological stress induced with adenosine 140 μg/kg/min for three minutes). An independent central reader performed the cardiac image analysis of all time points including the calculation of the myocardial perfusion reserve index from the ratio of the global stress myocardial blood flow divided by the resting blood flow values. Higher/increased index indicates improved flow/better outcome. This primary endpoint was only for Part A, Cohort 1 patients.'}, {'measure': 'Change From Baseline in Total Exercise Duration (Part A, Cohort 1)', 'timeFrame': 'Baseline and on day 5 of each of the two treatment periods', 'description': 'Total exercise duration was the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue. This primary endpoint was only for Part A, Cohort 1 patients.'}, {'measure': 'Time to Onset of Angina (Part A, Cohort 1)', 'timeFrame': 'Baseline and on day 5 of each of the two treatment periods', 'description': 'Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the patient and recorded by the performing investigator.'}, {'measure': 'Time to Onset of Exercise-induced Ischemia(Part A, Cohort 1)', 'timeFrame': 'Baseline and on day 5 of each of the two treatment periods', 'description': 'Exercise-induced ischemia was defined as the new development of horizontal or down-sloping ST-segment depression (≥ 1mm at 60 milliseconds after the J point) versus baseline tracings.'}, {'measure': 'Aortic Plaque Inflammation (Part B)', 'timeFrame': 'Baseline and on treatment day 85 +/- 3 days', 'description': 'This endpoint was palnned for analysis on Part B patients which was never started becasue study got terminated on Part A interim analysis.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (Part A, Cohort 1)', 'timeFrame': 'approximately 40 days'}, {'measure': 'Number of Participants With Adverse Events (Part A, Cohort 2)', 'timeFrame': 'approximately 40 days'}, {'measure': 'Postprandial Triglycerides (Part A, Cohort 1)', 'timeFrame': '0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5', 'description': 'For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour(before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.'}, {'measure': 'Postprandial Triglycerides (Part A, Cohort 2)', 'timeFrame': '0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5', 'description': 'For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour (before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.'}, {'measure': 'Pharmacokinetics of Pradigastat (LCQ908): Plasma Concentration (Part A)', 'timeFrame': 'Part A: Day 4 and day 5 of each treatment period'}, {'measure': 'Other Related Lipid Parameters (Part A)', 'timeFrame': 'Baseline, day 4 and day 5 of each treatment period'}, {'measure': 'Interleukin-6 (IL-6) Level (Part A)', 'timeFrame': 'Baseline, day 4 and day 5, of each treatment period'}, {'measure': 'C-reactive Protein (CRP) Level (Part A)', 'timeFrame': 'Baseline, day 4 and day 5, of each treatment period'}, {'measure': 'Adiponectin Level ( Part B)', 'timeFrame': 'Part B; Baseline, day 15, day 43 and day 85'}]}, 'conditionsModule': {'keywords': ['coronary artery disease,', 'LCQ908,', 'hyperlipidemia,', 'hypertriglyceridemia,', 'pradigastat'], 'conditions': ['Coronary Artery Disease', 'Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact cardiovascular risk.', 'detailedDescription': 'This study had 2 parts. Part A was a multicenter, double-blind, randomized, placebo-controlled, non-confirmatory crossover study assessing response to a high-fat meal challenge in the setting of pradigastat versus placebo. Part A had 2 cohorts i.e. Cohort 1 patients with stable coronary artery disease and hypertriglyceridemia and Cohort 2 patients with asymptomatic non-obstructive coronary artery disease or elevated coronary heart disease risk and hypertriglyceridemia.\n\nPart B was a double blinded phase designed to assess response to three months of chronic treatment with pradigastat versus placebo on a normal diet.\n\nThe trial was terminated after the interim analysis of Part A, Cohort 1. The interim analysis results indicated that the high-fat meal challenge did not induce any impairment on either myocardial perfusion reserve index (MPRi) or exercise treadmill performance. Part B was never started.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of coronary artery disease\n* Elevated triglycerides\n* On medication to help lower cholesterol\n\nExclusion Criteria:\n\n* Poorly controlled diabetic patients and/or change in diabetic medication within 12 weeks of screening\n* History of myocardial infarction (heart attack) within 6 months of screening\n* History of a procedure to open a blocked coronary artery within 12 months of enrollment\n* History of Coronary Artery Bypass Graft (CABG) surgery\n* History of congestive heart failure\n* History of significant heart valve disease'}, 'identificationModule': {'nctId': 'NCT01474434', 'briefTitle': 'Efficacy of LCQ908 on Cardiovascular Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of LCQ908 on Cardiovascular Risk', 'orgStudyIdInfo': {'id': 'CLCQ908A2213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pradigastat (LCQ908) followed by placebo', 'description': 'Pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment', 'interventionNames': ['Drug: pradigastat (LCQ908)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo followed by pradigastat (LCQ908)', 'description': 'Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by p20 mg (2 x 10-mg tablets) daily for two days', 'interventionNames': ['Drug: pradigastat (LCQ908)', 'Drug: Placebo']}], 'interventions': [{'name': 'pradigastat (LCQ908)', 'type': 'DRUG', 'otherNames': ['Pradigastat'], 'description': 'pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs.', 'armGroupLabels': ['Placebo followed by pradigastat (LCQ908)', 'Pradigastat (LCQ908) followed by placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo tablets', 'armGroupLabels': ['Placebo followed by pradigastat (LCQ908)', 'Pradigastat (LCQ908) followed by placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}