Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin - 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 pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Fenofibrate/Simvastatin Drug: Pravastatin	Phase III

ChemIDplus related topics:

Pravastatin Pravastatin sodium 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 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin Alone

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Percent change from baseline to 12 weeks of treatment 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 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 ]

Enrollment:	423
Study Start Date:	September 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 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

Criteria

Inclusion Criteria:

Mixed dyslipidemia

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362206

Show 41 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 04, 2006-000515-15
First Received:	August 8, 2006
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00362206
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

Keywords provided by Solvay Pharmaceuticals:

Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin

Hyperlipidemia Combined

Study placed in the following topic categories:

Pravastatin

Metabolic Diseases

Hyperlipidemias

Simvastatin

Metabolic disorder

Procetofen

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:	NCT00362206