Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 7:47 PM
Study NCT ID:
NCT00769132
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2008-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'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': 'C518174', 'term': 'MK-0524'}, {'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Although 26 participants were included in the assessment of safety, not all participants received all treatments.', 'eventGroups': [{'id': 'EG000', 'title': 'ER Niacin 2 g / Laropiprant 40 mg', 'description': 'ER niacin 2 g/laropiprant 40 mg once daily for 7 days', 'otherNumAtRisk': 25, 'otherNumAffected': 15, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ER Niacin 2 g', 'description': 'ER niacin 2 g once daily for 7 days', 'otherNumAtRisk': 24, 'otherNumAffected': 21, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Laropiprant 40 mg', 'description': 'Laropiprant 40 mg once daily for 7 days', 'otherNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo once daily for 7 days', 'otherNumAtRisk': 25, 'otherNumAffected': 5, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'General Disorders And Administration Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Musculoskeletal And Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Renal And Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Skin And Subcutaneous Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pruritus Generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary 11-dehydrothromboxane B2 (11-dTxB2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ER Niacin 2 g / Laropiprant 40 mg', 'description': 'ER niacin 2 g/laropiprant 40 mg daily for 7 days'}, {'id': 'OG001', 'title': 'ER Niacin 2 g', 'description': 'ER niacin 2 g daily for 7 days'}, {'id': 'OG002', 'title': 'Laropiprant 40 mg', 'description': 'Laropiprant 40 mg once daily for 7 days'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '414.6', 'groupId': 'OG000', 'lowerLimit': '316.8', 'upperLimit': '542.6'}, {'value': '371.6', 'groupId': 'OG001', 'lowerLimit': '283.8', 'upperLimit': '486.5'}, {'value': '407.3', 'groupId': 'OG002', 'lowerLimit': '312.2', 'upperLimit': '531.4'}, {'value': '466.1', 'groupId': 'OG003', 'lowerLimit': '358.4', 'upperLimit': '606.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '1.12', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.38', 'groupDescription': 'The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \\[Treatment A/B\\] of the urine levels of 11-dTxB2 on Day 7.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Two treatments are comparable if the geometric mean ratio is contained within the interval \\[0.50-2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.87', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.07', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.8', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.98', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.09', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.91', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '1.02', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.25', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day 7 across the 24-hour urinary collection period.', 'description': 'The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.', 'unitOfMeasure': 'pg/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.'}, {'type': 'SECONDARY', 'title': 'Prostaglandin I Metabolite (PGI-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ER Niacin 2 g / Laropiprant 40 mg', 'description': 'ER niacin 2 g/laropiprant 40 mg daily for 7 days'}, {'id': 'OG001', 'title': 'ER Niacin 2 g', 'description': 'ER niacin 2 g daily for 7 days'}, {'id': 'OG002', 'title': 'Laropiprant 40 mg', 'description': 'Laropiprant 40 mg once daily for 7 days'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '88.1'}, {'value': '70.9', 'groupId': 'OG001', 'lowerLimit': '59.2', 'upperLimit': '85.0'}, {'value': '114.5', 'groupId': 'OG002', 'lowerLimit': '95.6', 'upperLimit': '137.2'}, {'value': '127.5', 'groupId': 'OG003', 'lowerLimit': '106.6', 'upperLimit': '152.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '1.04', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.01', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.56', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.63', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.58', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.65', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.62', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.64', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.72', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day 7 across the 24-hour urinary collection period.', 'description': 'The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.', 'unitOfMeasure': 'pg/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: D/C/A/B', 'description': 'A = Extended Release (ER) niacin 2 g/laropiprant 40 mg once daily for 7 days\n\nB = ER niacin 2 g once daily for 7 days\n\nC = laropiprant 40 mg once daily for 7 days\n\nD = placebo once daily for 7 days'}, {'id': 'FG001', 'title': 'Sequence 2: C/B/D/A', 'description': 'A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days\n\nC = laropiprant 40 mg once daily for 7 days\n\nD = placebo once daily for 7 days'}, {'id': 'FG002', 'title': 'Sequence 3: B/A/C/D', 'description': 'A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days\n\nC = laropiprant 40 mg once daily for 7 days\n\nD = placebo once daily for 7 days'}, {'id': 'FG003', 'title': 'Sequence 4: A/D/B/C', 'description': 'A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days\n\nB = ER niacin 2 g once daily for 7 days\n\nC = laropiprant 40 mg once daily for 7 days\n\nD = placebo once daily for 7 days'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Phase I\n\nFirst Patient Entered 16 Aug 2007.\n\nStudy conducted at Comprehensive Phase One, Miramar, FL. and Cedra Clinical Research LLC, San Antonio, TX.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Totals for Study', 'description': 'All participants in the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '11.6', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '165.5', 'groupId': 'BG000', 'lowerLimit': '147.0', 'upperLimit': '185.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.4', 'groupId': 'BG000', 'lowerLimit': '58.0', 'upperLimit': '102.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'urinary 11-dTxB2', 'classes': [{'categories': [{'measurements': [{'value': '418.5', 'groupId': 'BG000', 'lowerLimit': '142.0', 'upperLimit': '783.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'urinary levels of 11-dehydrothromboxane B2 (24 hour collection)', 'unitOfMeasure': 'pg/mg creatinine', 'dispersionType': 'FULL_RANGE'}, {'title': 'urinary PGI2-Metabolite', 'classes': [{'categories': [{'measurements': [{'value': '89.7', 'groupId': 'BG000', 'lowerLimit': '45.2', 'upperLimit': '242.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'urinary levels of 2,3-dinor 6-keto-PGF1a (Prostaglandin I-M) 24-hour collection', 'unitOfMeasure': 'pg/mg creatinine', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2007-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2008-10-07', 'resultsFirstSubmitDate': '2008-10-30', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2008-11-26', 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2008-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary 11-dehydrothromboxane B2 (11-dTxB2)', 'timeFrame': 'On Day 7 across the 24-hour urinary collection period.', 'description': 'The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.'}], 'secondaryOutcomes': [{'measure': 'Prostaglandin I Metabolite (PGI-M)', 'timeFrame': 'On Day 7 across the 24-hour urinary collection period.', 'description': 'The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.'}]}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '19833861', 'type': 'RESULT', 'citation': 'Lauring B, Dishy V, Luo WL, Laterza O, Patterson J, Cote J, Chao A, Larson P, Gutierrez M, Wagner JA, Lai E. Laropiprant in combination with extended-release niacin does not alter urine 11-dehydrothromboxane B2, a marker of in vivo platelet function, in healthy, hypercholesterolemic, and diabetic subjects. J Clin Pharmacol. 2009 Dec;49(12):1426-35. doi: 10.1177/0091270009339593. Epub 2009 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects may not be pregnant and/or will agree to use appropriate method of contraception beginning at least 2 weeks prior to administration of the first dose of study drug in the first treatment period, throughout the study and until at least 2 weeks after administration of the last dose of study drug in the last treatment period.\n* Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug.\n* Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug.\n* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months; subjects who have discontinued smoking or the use of nicotine/nicotine containing products for at least approximately 3 months may be enrolled in the study at the discretion of the investigator\n\nExclusion Criteria:\n\n* Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 to 10 years. - Subjects who have had situational depression may be enrolled in the study at the discretion of the investigator.\n* Subject has a history of stroke, chronic seizures, or major neurological disorder.\n* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.\n* Subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment.\n* Subject has history of a thrombotic or platelet related disorder including prior deep venous thrombosis. Subject is being treated with coumadin, heparin, clopidogrel has used these agents within 2 weeks of screening. Subject is being treated with aspirin or has used this agent within 3 weeks prior to administration of screening.\n* Subject is unable to refrain from or anticipates the use of any medication, including prescription and non- prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of study drug, throughout the study until the poststudy visit.\n* Subject consumes excessive amounts of alcohol, defined as greater than 3 glasses, of alcoholic beverages or distilled spirits per day.\n* Subject consumes excessive amounts, defined as greater than 6 servings, of coffee, tea, cola, or other caffeinated beverages per day.\n* Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.\n* Subject has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.\n* Subject is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months.'}, 'identificationModule': {'nctId': 'NCT00769132', 'briefTitle': 'A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With Hypercholesterolemia', 'orgStudyIdInfo': {'id': '0524A-075'}, 'secondaryIdInfos': [{'id': '2008_561'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'ER niacin/laropiprant + Placebo to laropiprant', 'interventionNames': ['Drug: Comparator: niacin + laropiprant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'ER niacin + Placebo to laropiprant', 'interventionNames': ['Drug: Comparator: niacin']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'laropiprant + Placebo to ER niacin/laropiprant', 'interventionNames': ['Drug: Comparator: laropiprant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: placebo']}], 'interventions': [{'name': 'Comparator: niacin + laropiprant', 'type': 'DRUG', 'description': 'ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days', 'armGroupLabels': ['A']}, {'name': 'Comparator: niacin', 'type': 'DRUG', 'otherNames': ['Niaspan'], 'description': 'ER niacin 2 g tablet once daily for 7 days', 'armGroupLabels': ['B']}, {'name': 'Comparator: laropiprant', 'type': 'DRUG', 'description': 'laropiprant 40 mg once daily for 7 days', 'armGroupLabels': ['C']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'matching placebo tablets for each of the interventions once daily for 7 days', 'armGroupLabels': ['D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}