Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00362934

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 atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Condition	Intervention	Phase
Hyperlipidemia	Drug: fenofibrate / simvastatin Drug: Atorvastatin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone

Resource links provided by NLM:

Drug Information available for: Fenofibrate Simvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	516
Study Start Date:	October 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: fenofibrate / simvastatin Combination of fenofibrate and simvastatin 20 mg and 40 mg
Active Comparator: 2	Drug: Atorvastatin Atorvastatin 10 mg and 20mg

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mixed dyslipidemia.

Exclusion Criteria:

Known hypersensitivity to fenofibrates or simvastatin or atorvastatin
Pregnant or lactating women
Contra-indication to fenofibrate or simvastatin or atorvastatin
Unstable or severe cardiac disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362934

Show 68 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Martine Guy, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00362934 History of Changes
Other Study ID Numbers:	C LF0242780-01 05 03, 2006-000519-21
Study First Received:	August 11, 2006
Last Updated:	July 7, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Czech Republic: State Institute for Drug Control Slovakia: State Institute for Drug Control Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Hyperlipidemia Combined
efficacy combination fenofibrate simvastatin versus atorvastatin

Additional relevant MeSH terms:

Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Simvastatin
Atorvastatin
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 24, 2012