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Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00349375
Recruitment Status : Completed
First Posted : July 7, 2006
Last Update Posted : July 8, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hyperlipidemia Drug: Fenofibrate/Simvastatin Drug: Simvastatin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate 145mg and Simvastatin 20mg
Experimental: 2 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
Active Comparator: 3 Drug: Simvastatin
Simvastatin 40 mg


Outcome Measures

Primary Outcome Measures :
  1. Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 12 weeks ]
  2. Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 12 weeks ]
  3. Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ]
  2. Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 24 weeks ]
  3. Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349375


  Show 110 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information

Responsible Party: Martine Guy, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00349375     History of Changes
Other Study ID Numbers: C LF0242780-01 05 01
2005-003270-14
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009

Keywords provided by Solvay Pharmaceuticals:
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors