Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 1:20 AM
Study NCT ID:
NCT00378833
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2006-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Chile', 'Colombia', 'Israel', 'Mexico', 'New Zealand', 'Peru', 'Switzerland', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}, {'id': 'C518174', 'term': 'MK-0524'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2006-09-20', 'studyFirstSubmitQcDate': '2006-09-20', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Flushing Severity Score (GFSS) over 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety/tolerability'}]}, 'conditionsModule': {'keywords': ['Primary Hypercholesterolemia or Mixed Hyperlipidemia'], 'conditions': ['Hypercholesterolemia', 'Hyperlipidemia']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR synopsis'}], 'references': [{'pmid': '19576324', 'type': 'RESULT', 'citation': 'Maccubbin D, Koren MJ, Davidson M, Gavish D, Pasternak RC, Macdonell G, Mallick M, Sisk CM, Paolini JF, Mitchel Y. Flushing profile of extended-release niacin/laropiprant versus gradually titrated niacin extended-release in patients with dyslipidemia with and without ischemic cardiovascular disease. Am J Cardiol. 2009 Jul 1;104(1):74-81. doi: 10.1016/j.amjcard.2009.02.047.'}]}, 'descriptionModule': {'briefSummary': 'This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides \\< 500 mg/dL\n\nExclusion Criteria:\n\n* Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) \\>/= 130 mg/dL and/or not on a statin\n* Patients with diabetes and LDL-C \\>/= 130 mg/dL. Patients with \\>/= 2 heart disease risk factors and LDL-C \\>/= 160 mg/dL.\n* Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT00378833', 'briefTitle': 'Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release', 'orgStudyIdInfo': {'id': '0524A-054'}, 'secondaryIdInfos': [{'id': '2006_529'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'niacin (+) laropiprant', 'type': 'DRUG', 'otherNames': ['MK0524A'], 'description': 'Duration of Treatment: 18 Weeks'}, {'name': 'niacin', 'type': 'DRUG', 'description': 'Duration of Treatment: 18 Weeks'}]}, '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'}}}}