Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 9:08 PM
Study NCT ID:
NCT01274559
Status:
TERMINATED
Last Update Posted:
2024-05-22
First Post:
2010-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Brazil', 'Bulgaria', 'Chile', 'Colombia', 'Czechia', 'France', 'Germany', 'Hungary', 'India', 'Israel', 'Italy', 'Mexico', 'Netherlands', 'New Zealand', 'Peru', 'Philippines', 'Poland', 'Puerto Rico', 'Russia', 'Spain', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'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'}]}}, '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. SPONSOR review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'MK-0524A-133 was stopped prior to completion. Raw individual efficacy data were obtained but none of planned efficacy outcomes were summarized or analyzed. Only safety data were summarized.'}}, 'adverseEventsModule': {'timeFrame': 'up to 12 weeks', 'description': 'The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.', 'otherNumAtRisk': 572, 'otherNumAffected': 101, 'seriousNumAtRisk': 572, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)', 'otherNumAtRisk': 572, 'otherNumAffected': 16, 'seriousNumAtRisk': 572, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 52, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 100, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Puncture site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetic macroangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglyceride (TG) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo A-I at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TC at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C:HDL-C at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TG at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo B at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo B:Apo A-I at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TC:HDL-C at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lp(a) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo A-I at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TC at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '587'}, {'groupId': 'FG001', 'numSubjects': '586'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '572'}, {'groupId': 'FG001', 'numSubjects': '572'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}, {'groupId': 'FG001', 'numSubjects': '441'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '145'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'Phase 3 study HPS2-THRIVE (NCT00461630) did not meet its primary endpoint of reduction of major vascular events and had a significant increase in the incidence of some types of non-fatal serious adverse events. As a result, MK-0524A-133 was discontinued. Only individual data were obtained; none of the planned efficacy outcomes were summarized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '587', 'groupId': 'BG000'}, {'value': '586', 'groupId': 'BG001'}, {'value': '1173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Extended-release Niacin/Laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '21 to 30 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '31 to 40 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': '41 to 50 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': '51 to 60 years', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}]}, {'title': '61 to 70 years', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}]}, {'title': '71 to 80 years', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}, {'title': '>80 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '482', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '348', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '691', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1173}}, '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': '2011-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2013-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2010-10-25', 'resultsFirstSubmitDate': '2014-01-30', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-30', 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)', 'timeFrame': 'Baseline and Week 12'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in HDL-C at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Triglyceride (TG) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Apo A-I at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in TC at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in LDL-C at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in LDL-C:HDL-C at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in HDL-C at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in TG at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in Apo B at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in Apo B:Apo A-I at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in TC:HDL-C at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in Lp(a) at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in Apo A-I at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Percent Change From Baseline in TC at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment', 'timeFrame': 'Baseline and 12 weeks', 'description': 'assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MK-0524A/ER', 'Hypercholesterolemia', 'Dyslipidemia', 'Niacin', 'Laropiprant'], 'conditions': ['Primary Hypercholesterolemia', 'Mixed Dyslipidemia']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0524A-133&kw=0524A-133&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant \\[ERN/LRPT (MK-0524A)\\] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin,\n\natorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a history of primary hypercholesterolemia or mixed dyslipidemia.\n* Must meet one of the risk categories (very high, high or moderate and corresponding LDL-C criteria at Visit 2.\n* Has TG levels \\<500 mg/dL (\\<5.65 mmol/L).\n* Has been on a stable dose of one of the following lipid-modifying therapies (LMTs)for at least 6 weeks prior to Visit 1, and agrees to remain on the same type and dose of LMT for the duration of the study:\n\n * Monotherapy: any statin\n * Combination Therapy: ezetimibe/simvastatin in the same tablet\n * Co-administration Therapy: any statin co-administered with ezetimibe\n* Is male or female and ≥18 years of age on day of signing informed consent.\n* A female must meet ONE of the following:\n\n * Of reproductive potential and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the study duration.\n * Not of reproductive potential is eligible without requiring the use of contraception. Definition of "not of reproductive potential": one who has either of the following:\n\n * reached natural menopause, defined as: 6 months of spontaneous amenorrhea with serum FSH levels (at Visit 1) in the postmenopausal range (per central lab) or 12 months of spontaneous amenorrhea.Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g., anorexia nervosa).\n * 6 weeks post surgical hysterectomy, or bilateral oophorectomy with or without hysterectomy.\n * Bilateral tubal ligation without subsequent restorative procedure.\n* Understands the study\'s procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.\n\nExclusion Criteria\n\n\\- Has taken a prohibited LMT within 6 weeks of Visit 1. Examples of\n\nprohibited LMT include bile acid sequestrants, fibrates (monotherapy, coadministration or combination with other LMT), niacin \\>50 mg, and red yeast rice products.\n\n* Has had a change to the type or dose of acceptable LMT regimen within 6 weeks of Visit 1.\n* Is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day poststudy follow-up.\n* Has a 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* Female who is expecting to donate eggs during the study, including the 14-day follow-up.\n* Is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.\n* Has participated in a study, including post-study follow-up, with an investigational compound (non-lipid-modifying) within 30 days of Visit 1 or a lipid-modifying compound (investigational or marketed), within 6 weeks of Visit 1.\n* Has donated and/or received blood as follows:\n\n * donated blood products or has had phlebotomy of \\>300 mL within 8 weeks prior to signing informed consent.\n * intends to give or receive blood products during the study.\n * intends to donate more than 250 mL of blood products within 8 weeks following the last study visit.\n* Has the following exclusionary laboratory values at Visit 2\n\n * Creatinine clearance (eGFR) \\<30 mL/min (0.50 mL/s)\n * ALT (SGPT) \\>1.5 x ULN\n * AST (SGOT) \\>1.5 x ULN\n * CK \\>2 x ULN\n* Has used recreational or illicit drugs within 1 year of signing informed consent.\n* Was \\<80% compliant with LMT or placebo at Visit 2, AND in the opinion of the investigator, is believed to be unable to maintain at least 80% compliance with dosing during the active treatment period.\n* Has chronic heart failure defined by the New York Heart Association (NYHA) Classes III or IV, uncontrolled cardiac arrhythmias, or poorly controlled hypertension (systolic blood pressure \\>160 mm Hg or diastolic \\>100 mm Hg).\n* Has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria:\n\n * Is poorly controlled (HbA1C \\>8.0% at Visit 1)\n * Is newly diagnosed (within 3 months of Visit 1)\n * Has recently experienced repeated hypoglycemia or unstable glycemic control (within 3 months of Visit 1).\n * Is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ± ≤ 10 units of insulin) within 3 months of Visit 1.\n* Has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia such as hyper- or hypothyroidism.\n* Has nephrotic syndrome or other clinically significant renal disease.\n* Has active peptic ulcer disease within 3 months of Visit 1.\n* Has a history of hypersensitivity or allergic reaction to niacin or niacin containing products.\n* Has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.\n* Has arterial bleeding.\n* Has a history of ileal bypass, gastric bypass or other significant condition associated with malabsorption or rapid weight loss within 18 months of Visit 1.\n* Has active or chronic hepatobiliary or hepatic disease.\n* Is Chinese and is on simvastatin 80 mg or a product containing simvastatin 80 mg at Visit 1.\n* Is receiving treatment with systemic steroids (intravenous, injected, and oral steroids) OR systemic anabolic agents.\n* Consumes more than 3 alcoholic drinks on any given day or more than 14 drinks per week.\n* Is taking the following antioxidant vitamins each day:\n\n * Vitamin C in excess of 1500 mg\n * Vitamin E in excess of 45 IU for men, 36 IU for women\n * Beta Carotene 15000 IU for men, 12000 IU for women'}, 'identificationModule': {'nctId': 'NCT01274559', 'briefTitle': 'Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia', 'orgStudyIdInfo': {'id': '0524A-133'}, 'secondaryIdInfos': [{'id': 'CTRI/2012/08/002857', 'type': 'REGISTRY', 'domain': 'CTRI'}, {'id': '2010-021627-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended-release niacin/laropiprant', 'description': 'ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.', 'interventionNames': ['Drug: Extended-release niacin/laropiprant (ERN/LRPT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Extended-release niacin/laropiprant (ERN/LRPT)', 'type': 'DRUG', 'description': '1 oral 1 g tablet of ERN/LRPT to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of ERN/LRPT to be taken together in the evening or at bedtime with food for the next 8 weeks. Each 1g tablet contains 1g ERN and 20 mg LRPT', 'armGroupLabels': ['Extended-release niacin/laropiprant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 oral 1 g tablet of placebo to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of placebo to be taken together in the evening or at bedtime with food for the next 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}