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Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362206
First Posted: August 9, 2006
Last Update Posted: July 8, 2009
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.
Information provided by:
Solvay Pharmaceuticals
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 12 weeks ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 12 weeks ]
  • Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 24 weeks ]
  • Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 24 weeks ]

Enrollment: 423
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 20mg
Experimental: 2 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
Active Comparator: 3 Drug: Pravastatin
Pravastatin 40 mg

  Eligibility

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 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
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): NCT00362206


  Show 41 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: NCT00362206     History of Changes
Other Study ID Numbers: C LF0242780-01 05 04
2006-000515-15
First Submitted: August 8, 2006
First Posted: August 9, 2006
Last Update Posted: July 8, 2009
Last Verified: July 2009

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

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