Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-02 @ 8:46 AM
Study NCT ID:
NCT00618995
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518174', 'term': 'MK-0524'}]}}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'ER Niacin/Laropiprant', 'description': 'Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days', 'otherNumAtRisk': 23, 'otherNumAffected': 17, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ER Niacin', 'description': 'ER Niacin 2 g once daily for 7 days', 'otherNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Laropiprant', 'description': 'Laropiprant 40 mg once daily for 7 days', 'otherNumAtRisk': 23, 'otherNumAffected': 12, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo once daily for 7 days', 'otherNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Feeling Hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Burning Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary 11-Dehydrothromboxane B2 (11-dTxB2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ER Niacin/Laropiprant', 'description': 'Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days'}, {'id': 'OG001', 'title': 'ER Niacin', 'description': 'ER Niacin 2 g once daily for 7 days'}, {'id': 'OG002', 'title': 'Laropiprant', 'description': 'Laropiprant 40 mg once daily for 7 days'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo once daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '525.3', 'groupId': 'OG000', 'lowerLimit': '423.8', 'upperLimit': '651.1'}, {'value': '540.8', 'groupId': 'OG001', 'lowerLimit': '435.0', 'upperLimit': '672.3'}, {'value': '585.3', 'groupId': 'OG002', 'lowerLimit': '472.2', 'upperLimit': '725.4'}, {'value': '625.1', 'groupId': 'OG003', 'lowerLimit': '504.3', 'upperLimit': '774.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.97', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.18', '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', 'testedNonInferiority': True, 'nonInferiorityComment': 'Two treatments are comparable if the geometric mean ratio (GMR) is contained within the interval \\[0.50-2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.87', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.05', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.84', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.02', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.92', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.13', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.09', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], '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 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.'}, {'type': 'SECONDARY', 'title': 'Prostaglandin I Metabolite (PGI-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ER Niacin/Laropiprant', 'description': 'Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days'}, {'id': 'OG001', 'title': 'ER Niacin', 'description': 'ER Niacin 2 g once daily for 7 days'}, {'id': 'OG002', 'title': 'Laropiprant', 'description': 'Laropiprant 40 mg once daily for 7 days'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo once daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '74.5', 'upperLimit': '109.0'}, {'value': '95.4', 'groupId': 'OG001', 'lowerLimit': '78.7', 'upperLimit': '115.5'}, {'value': '158.5', 'groupId': 'OG002', 'lowerLimit': '131.0', 'upperLimit': '191.8'}, {'value': '168.1', 'groupId': 'OG003', 'lowerLimit': '139.0', 'upperLimit': '203.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.06', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.05', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.57', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.64', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.54', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.60', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.60', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.67', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric least-squares mean ratio', 'ciPctValue': '90', 'paramValue': '0.57', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.64', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day 7 across the 24-hour urinary collection period.', 'description': '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 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: D/C/A/B', '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'}, {'id': 'FG001', 'title': 'Sequence 2: C/B/D/A', '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'}, {'id': 'FG002', 'title': 'Sequence 3: B/A/C/D', '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'}, {'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': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Phase I\n\nFirst Patient Enrolled 21 Aug 2007, First Patient Treated 7 Sept 2007.\n\nStudy conducted at 3 centers: Arkansas Research Medical Testing, LLC, Little Rock, AR; Healthcare Discoveries Inc., San Antonio, TX; and Comprehensive Phase One, Fort Myers, FL. Merck's ER Niacin was used.", 'preAssignmentDetails': 'Subjects were treated either w/diet and exercise alone, or with metformin, or a sulfonylurea, and had to be on stable meds for \\>= 8 wks pre-study.'}, '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': '55.3', 'spread': '6.7', 'groupId': 'BG000'}]}]}], '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': '163.9', 'groupId': 'BG000', 'lowerLimit': '150', 'upperLimit': '181.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'groupId': 'BG000', 'lowerLimit': '55.0', 'upperLimit': '127.2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'urinary 11-dTxB2', 'classes': [{'categories': [{'measurements': [{'value': '639.1', 'groupId': 'BG000', 'lowerLimit': '304.5', 'upperLimit': '1045.6'}]}]}], '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': '167.5', 'groupId': 'BG000', 'lowerLimit': '79.4', 'upperLimit': '356.0'}]}]}], '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'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2008-02-08', 'resultsFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-02-04', 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', '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': 'PGI-M in the Overall 24 Hour Collection Interval Following Administration on Day 7'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, '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 specific metabolite (which is a marker of in vivo platelet reactivity).', 'detailedDescription': 'Subjects will receive 1 of 4 treatments per period and will eventually receive all 4 treatments:\n\nTreatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days\n\nTreatment B: ER niacin 2 g daily + Placebo to laropiprant for 7\n\ndays\n\nTreatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days\n\nTreatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing on Day 7 of a period and dosing on Day 1 of the subsequent period'}, '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 has a history of T2DM either treated with diet and exercise alone or with metformin or a sulfonylurea\n* Subject is judged to be in good health (other than history of Type 2 diabetes mellitus) 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\n* Subject has a history of stroke, chronic seizures, or major neurological disorder\n* Subject has a history of clinically significant endocrine (except for Type 2 diabetes mellitus), 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 blood or platelet related disorder including prior deep venous thrombosis. Subject is being treated with coumadin, heparin, clopidogrel or 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 (with the exception of metformin or sulfonylurea agents), including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks until the post-study visit. No concomitant medications may be taken during the study\n* Subject consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, per day\n* Subject consumes excessive amounts, defined as greater than 6, 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 uses insulin, PPAR gamma agonists (rosiglitazone or pioglitazone), exenatide (Byetta), acarbose (Prandase, Precose) or dipeptidyl-peptidase 4 (DPP-4) inhibitors (JANUVIA™1)'}, 'identificationModule': {'nctId': 'NCT00618995', 'briefTitle': 'A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(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 Type 2 Diabetes', 'orgStudyIdInfo': {'id': '0524A-079'}, 'secondaryIdInfos': [{'id': '2008_508'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Arm A: ER niacin/laropiprant + Placebo to laropiprant', 'interventionNames': ['Drug: Comparator: ER niacin (+) laropiprant']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Arm B: ER niacin + Placebo to laropiprant', 'interventionNames': ['Drug: Comparator: ER niacin']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Arm C: laropiprant + Placebo to ER Niacin/laropiprant', 'interventionNames': ['Drug: Comparator: laropiprant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'description': 'Arm D: Placebo', 'interventionNames': ['Drug: Comparator: placebo']}], 'interventions': [{'name': 'Comparator: ER niacin (+) laropiprant', 'type': 'DRUG', 'description': 'ER niacin 2 g/ laropiprant 40 mg daily for 7 days.', 'armGroupLabels': ['A']}, {'name': 'Comparator: ER niacin', 'type': 'DRUG', 'description': 'ER niacin 2 g daily for 7 days.', 'armGroupLabels': ['B']}, {'name': 'Comparator: laropiprant', 'type': 'DRUG', 'description': 'laropiprant 40 mg 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'}}}}