Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-22 @ 10:03 PM
Study NCT ID:
NCT00092651
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2004-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2004-09-23', 'studyFirstSubmitQcDate': '2004-09-27', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma LDL-C', 'timeFrame': 'From baseline to study end point, defined in this study as the last available postbaseline LDL-C measurement, after 12 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.', 'timeFrame': 'From baseline to study end point in TC, TG, HDL-C, ratios of direct LDL-C:HDL-C and TC:HDL-C, non-HDL-C, Apo B, Apo A-I, Apo A-II, Apo E, lipoprotein(a), C[1]reactive protein (CRP), and fibrinogen, after 12 weeks of treatment.'}]}, 'conditionsModule': {'keywords': ['Primary hypercholesterolemia'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '15639688', 'type': 'BACKGROUND', 'citation': 'Bays HE, Ose L, Fraser N, Tribble DL, Quinto K, Reyes R, Johnson-Levonas AO, Sapre A, Donahue SR; Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004 Nov;26(11):1758-73. doi: 10.1016/j.clinthera.2004.11.016.'}, {'pmid': '16709304', 'type': 'BACKGROUND', 'citation': 'Ose L, Shah A, Davies MJ, Rotonda J, Maccubbin D, Tribble D, Veltri E, Mitchel Y. Consistency of lipid-altering effects of ezetimibe/simvastatin across gender, race, age, baseline low density lipoprotein cholesterol levels, and coronary heart disease status: results of a pooled retrospective analysis. Curr Med Res Opin. 2006 May;22(5):823-35. doi: 10.1185/030079906X100131.'}, {'pmid': '16860168', 'type': 'BACKGROUND', 'citation': 'Feldman T, Davidson M, Shah A, Maccubbin D, Meehan A, Zakson M, Tribble D, Veltri E, Mitchel Y. Comparison of the lipid-modifying efficacy and safety profiles of ezetimibe coadministered with simvastatin in older versus younger patients with primary hypercholesterolemia: a post Hoc analysis of subpopulations from three pooled clinical trials. Clin Ther. 2006 Jun;28(6):849-59. doi: 10.1016/j.clinthera.2006.06.001.'}, {'pmid': '18370810', 'type': 'BACKGROUND', 'citation': 'Feldman T, Ose L, Shah A, Zakson M, Meehan A, Johnson-Levonas AO, Maccubbin D, Tribble DL, Veltri E, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin versus simvastatin monotherapy in hypercholesterolemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Spring;5(1):13-21. doi: 10.1089/met.2006.0033.'}, {'pmid': '18158082', 'type': 'BACKGROUND', 'citation': 'Ose L, Reyes R, Johnson-Levonas AO, Sapre A, Tribble DL, Musliner T. Effects of ezetimibe/simvastatin on lipoprotein subfractions in patients with primary hypercholesterolemia: an exploratory analysis of archived samples using two commercially available techniques. Clin Ther. 2007 Nov;29(11):2419-32. doi: 10.1016/j.clinthera.2007.10.004.'}, {'pmid': '17560879', 'type': 'BACKGROUND', 'citation': 'Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).', 'detailedDescription': 'The duration of treatment is 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High cholesterol\n\nExclusion Criteria:\n\n* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.'}, 'identificationModule': {'nctId': 'NCT00092651', 'briefTitle': 'A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia', 'orgStudyIdInfo': {'id': '0653A-038'}, 'secondaryIdInfos': [{'id': '2004_048'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0653A, ezetimibe (+) simvastatin', 'type': 'DRUG'}, {'name': 'Comparators: simvastatin and ezetimibe', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}