Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-31 @ 1:54 AM
Study NCT ID:
NCT00092157
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2004-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'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': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2003-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2004-09-21', 'studyFirstSubmitQcDate': '2004-09-23', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting triglyceride levels at 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin'}]}, 'conditionsModule': {'keywords': ['High cholesterol'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '15695129', 'type': 'BACKGROUND', 'citation': 'Grundy SM, Vega GL, Yuan Z, Battisti WP, Brady WE, Palmisano J. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am J Cardiol. 2005 Feb 15;95(4):462-8. doi: 10.1016/j.amjcard.2004.10.012.'}, {'pmid': '19660610', 'type': 'BACKGROUND', 'citation': 'Grundy SM, Vega GL, Tomassini JE, Tershakovec AM. Correlation of non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol with apolipoprotein B during simvastatin + fenofibrate therapy in patients with combined hyperlipidemia (a subanalysis of the SAFARI trial). Am J Cardiol. 2009 Aug 15;104(4):548-53. doi: 10.1016/j.amjcard.2009.04.018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.', 'detailedDescription': 'The duration of treatment is 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elevated cholesterol level\n\nExclusion Criteria:\n\n* Liver disease\n* Known allergies to study drugs'}, 'identificationModule': {'nctId': 'NCT00092157', 'briefTitle': 'Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patients With Combined Hyperlipidemia-Simvastatin and Fenofibrate Efficacy Trial (SAFARI)', 'orgStudyIdInfo': {'id': '0733-224'}, 'secondaryIdInfos': [{'id': '2004_060'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0733, simvastatin', 'type': 'DRUG'}, {'name': 'Comparator: simvastatin', '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'}}}}