Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT00385658
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2006-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], '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': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2006-10-10', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.'}], 'secondaryOutcomes': [{'measure': 'Compared at the end of each treatment period:'}, {'measure': 'patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl'}, {'measure': 'patients reaching target levels of non-HDL-C <130mg/'}, {'measure': 'LDL-C/HDL-C'}, {'measure': 'Triglycerides'}, {'measure': 'LDL subfractions in a subgroup of patients'}]}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'metabolic syndrome', 'fluvastatin', 'fenofibrate', 'simvastatin', 'ezetimibe'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent to participate in the study prior to any study procedures.\n* Male or female subjects, age between 18-75 years inclusive.\n* All women of child bearing potential must have a negative pregnancy test\n* Metabolic Syndrome according to the International Diabetes Federation definition:\n\n * Low plasma HDL-C (Men \\< 40 mg/dl ; Women \\< 50 mg/dl ).\n * Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)\n * And one or more of the following criteria:\n\n * Triglycerides ≥ 150 mg/d.l\n * Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.\n * Fasting plasma glucose≥ 100mg/dl.\n * Previously diagnosed type 2 diabetes.\n\nExclusion Criteria:\n\n* Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.\n* Type 1 diabetes.\n* HbA1c \\> 9.5%.\n* Unexplained serum creatine phosphokinase \\> 2 x Upper limit of normal.\n* History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.\n* Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00385658', 'briefTitle': 'Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'CXUO320BDE35'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluvastatin extended release, fenofibrate', 'type': 'DRUG'}, {'name': 'Fixed combination simvastatin/ezetimibe', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Investigative Centers', 'country': 'Germany'}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis Pharma AG', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Pharma AG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}