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

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00352183

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
Cardiovascular Diseases	Drug: Fenofibrate/Simvastatin Drug: Simvastatin	Phase III

Drug Information available for: Procetofen Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin 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, Apo B and LDL size; 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 ]

Enrollment:	450
Study Start Date:	January 2006
Study Completion Date:	August 2008
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 40mg
2: Active Comparator	Drug: Simvastatin Simvastatin 40mg

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:

Diabetes,
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: NCT00352183

Show 67 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 02, ACTRN012605000777695
Study First Received:	July 13, 2006
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00352183 History of Changes
Health Authority:	New Zealand: Health Research Council; Australia: Department of Health and Ageing Therapeutic Goods Administration; Estonia: The State Agency of Medicine; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Hyperlipidemia Combined
Combination of fenofibrate and simvastatin

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Simvastatin
Antilipemic Agents

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Dyslipidemias

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Simvastatin
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009