Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00349375

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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Fenofibrate/Simvastatin Drug: Simvastatin	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, Active Comparator, 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 Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

Resource links provided by NLM:

Drug Information available for: Procetofen Simvastatin

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	1040
Study Start Date:	November 2005
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 145mg and Simvastatin 20mg
2: Experimental	Drug: Fenofibrate/Simvastatin Combination of Fenofibrate and Simvastatin 40 mg
3: Active Comparator	Drug: Simvastatin Simvastatin 40 mg

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 fenofibrate or simvastatin
Pregnant or lactating women
Contra-indication to fenofibrate or simvastatin
Unstable or severe cardiac disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349375

Show 110 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Martine Guy )
Study ID Numbers:	C LF0242780-01 05 01, 2005-003270-14
Study First Received:	July 6, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00349375 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Hungary: National Institute of Pharmacy; Ukraine: Ministry of Health; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Netherlands: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Pharmacologic Actions
Therapeutic Uses
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010