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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00352183 |
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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
Condition | Intervention | Phase |
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Cardiovascular Diseases |
Drug: Fenofibrate/Simvastatin Drug: Simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin Alone. |
Estimated Enrollment: | 400 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40mg
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2: Active Comparator |
Drug: Simvastatin
Simvastatin 40mg
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Martine Guy ) |
Study ID Numbers: | C LF0242780-01 05 02, ACTRN012605000777695 |
Study First Received: | July 13, 2006 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00352183 |
Health Authority: | New Zealand: Health Research Council; Australia: Department of Health and Ageing Therapeutic Goods Administration; Estonia: The State Agency of Medicine; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health |
Hyperlipidemia Combined Combination of fenofibrate and simvastatin |
Hyperlipidemias Simvastatin Procetofen Dyslipidemias |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |