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| Sponsor: | Solvay Pharmaceuticals |
|---|---|
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00362206 |
Purpose
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 pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia |
Drug: Fenofibrate/Simvastatin Drug: Pravastatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin Alone |
| Enrollment: | 423 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 20mg
|
| 2: Experimental |
Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
|
| 3: Active Comparator |
Drug: Pravastatin
Pravastatin 40 mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 41 Study Locations| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Solvay Pharmaceuticals ( Martine Guy ) |
| Study ID Numbers: | C LF0242780-01 05 04, 2006-000515-15 |
| Study First Received: | August 8, 2006 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00362206 History of Changes |
| Health Authority: | Greece: National Organization of Medicines; Israel: Ministry of Health; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; South Africa: Medicines Control Council |
|
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin Hyperlipidemia Combined |
|
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Procetofen Pharmacologic Actions Pravastatin Therapeutic Uses Dyslipidemias Lipid Metabolism Disorders |