Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-21 @ 3:31 AM
Study NCT ID:
NCT00362934
Status:
COMPLETED
Last Update Posted:
2009-07-08
First Post:
2006-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'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': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, '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': 516}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-07', 'studyFirstSubmitDate': '2006-08-11', 'studyFirstSubmitQcDate': '2006-08-11', 'lastUpdatePostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline to 12 weeks of treatment in Triglycerides', 'timeFrame': '12 weeks'}, {'measure': 'Percent change from baseline to 12 weeks of treatment in HDL-C', 'timeFrame': '12 weeks'}, {'measure': 'Percent change from baseline to 12 weeks of treatment in LDL-C', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percent change from baseline to 12 weeks of treatment in Triglycerides', 'timeFrame': '24 weeks'}, {'measure': 'Percent change from baseline to 12 weeks of treatment in HDL-C', 'timeFrame': '24 weeks'}, {'measure': 'Percent change from baseline to 12 weeks of treatment in LDL-C', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'keywords': ['Hyperlipidemia Combined', 'efficacy combination fenofibrate simvastatin versus atorvastatin'], 'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mixed dyslipidemia.\n\nExclusion Criteria:\n\n* Known hypersensitivity to fenofibrates or simvastatin or atorvastatin\n* Pregnant or lactating women\n* Contra-indication to fenofibrate or simvastatin or atorvastatin\n* Unstable or severe cardiac disease'}, 'identificationModule': {'nctId': 'NCT00362934', 'briefTitle': 'Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone', 'orgStudyIdInfo': {'id': 'C LF0242780-01 05 03'}, 'secondaryIdInfos': [{'id': '2006-000519-21'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: fenofibrate / simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'fenofibrate / simvastatin', 'type': 'DRUG', 'description': 'Combination of fenofibrate and simvastatin 20 mg and 40 mg', 'armGroupLabels': ['1']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Atorvastatin 10 mg and 20mg', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haskovo', 'country': 'Bulgaria', 'facility': 'Site 501', 'geoPoint': {'lat': 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