Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 11:36 PM
Study NCT ID:
NCT01414166
Status:
TERMINATED
Last Update Posted:
2015-05-13
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Philippines']}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, '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': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the small number of participants completing the study (n=70), the resulting underpowered nature of any analyses that might be conducted, and the fact that data are not going to be used, no efficacy analyses were performed.'}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.', 'description': 'The safety population consisted of all participants that received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.', 'otherNumAtRisk': 120, 'otherNumAffected': 42, 'seriousNumAtRisk': 120, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.', 'otherNumAtRisk': 121, 'otherNumAffected': 17, 'seriousNumAtRisk': 121, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Impaired Fasting Glucose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Weeks 12 to 16', 'description': "The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': "The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides (TG) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, this efficacy endpoint was not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'This study took place at 37 centers in 2 countries (29 sites in India and 8 sites in Philippines).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ERN/LPRT', 'description': 'Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '9.30', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '10.18', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '9.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'whyStopped': 'In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2011-08-09', 'resultsFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2011-08-09', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-30', 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16', 'timeFrame': 'Baseline and Weeks 12 to 16', 'description': "The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16."}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16."}, {'measure': 'Percent Change From Baseline in HDL-C at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16."}, {'measure': 'Percent Change From Baseline in Triglycerides (TG) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' TG level was to be evaluated at study Week 16."}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16."}, {'measure': 'Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16."}, {'measure': 'Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* LMT ineligible\n* Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)\n* HDL-C \\<40 mg/dL (1.03 mmol/L) in males and \\<50 mg/dL (1.29 mmol/L) in females\n* Triglyceride (TG) level \\<300 mg/dL (3.39 mmol/L).\n* Fasting serum glucose (FSG) at Visit 1 AND Visit 2 \\<126 mg/dL (\\<7 mmol/L)\n* Hemoglobin A1c (HbA1c) level \\<6.5%\n* Participant willing to use acceptable method of contraception during the study, including the 14-day follow-up period\n\nExclusion criteria:\n\n* History of malignancy ≤5 years prior to signing informed consent, except for adequately-treated basal cell or squamous cell skin cancer or in situ cervical cancer\n* Participation in a study with an investigational compound (non-lipid-modifying) within 30 days\n* Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period\n* Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week\n* Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study\n* Diabetes mellitus, based on medical history, FSG ≥126 mg/dL (7 mmol/L), and HbA1c ≥6.5%\n* Risk factors for coronary heart disease\n* Active or chronic hepatobiliary or hepatic disease\n* Active peptic ulcer disease within 3 months of Visit 1\n* History of hypersensitivity or allergic reaction to niacin or niacin-containing products\n* Episode of gout within 1 year of Visit 1, unless currently stable on allopurinol\n* Taking an LMT (including statins, bile acid sequestrants, fibrates and niacin \\>50 mg as monotherapy or coadministered with other LMTs)\n* Use of over-the- counter or traditional medicine (e.g. red yeast rice products) for lipid-lowering\n* Receiving treatment with systemic corticosteroids (unless on stable therapy for at lest 6 weeks for replacement for pituitary/adrenal/hypogonadal disease)\n* Uncontrolled illness or infection'}, 'identificationModule': {'nctId': 'NCT01414166', 'briefTitle': 'Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A 16-Week, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Extended Release Niacin/Laropiprant in South and Southeast Asians Not on a Lipid Modulating Agent, With Decreased High-Density Lipoprotein Cholesterol and Low- Density Lipoprotein Cholesterol at or Below NCEP ATP III Goal', 'orgStudyIdInfo': {'id': '0524A-108'}, 'secondaryIdInfos': [{'id': 'CTRI/2012/08/002873', 'type': 'REGISTRY', 'domain': 'CTRI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERN/LRPT group', 'description': 'All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks.', 'interventionNames': ['Drug: ERN/LRPT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'ERN/LRPT', 'type': 'DRUG', 'otherNames': ['Tredaptive™'], 'description': 'ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks', 'armGroupLabels': ['ERN/LRPT group']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks', 'armGroupLabels': ['Placebo group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}