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

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 III

ChemIDplus related topics:

Atorvastatin Atorvastatin calcium Procetofen Simvastatin

U.S. FDA Resources

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 Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Percent change from baseline in TG, HDL-C and LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline in TG, HDL-C, LDL-C, non HDL-C, TC, Apo AI and Apo B; change from baseline in hs CRP and fibrinogen. Percentage of patients reaching the NCEP ATP III target LDL-C and TG levels. [ Time Frame: 12 and/or 24 weeks ] [ Designated as safety issue: No ]

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

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

Responsible Party:	Solvay Pharmaceuticals ( Martine Guy )
Study ID Numbers:	C LF0242780-01 05 03, 2006-000519-21
First Received:	August 11, 2006
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00362934
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

Study placed in the following topic categories:

Metabolic Diseases

Hyperlipidemias

Simvastatin

Metabolic disorder

Procetofen

Atorvastatin

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

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