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Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

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ClinicalTrials.gov Identifier: NCT00362934
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : July 8, 2009
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: fenofibrate / simvastatin Drug: Atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 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, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone
Study Start Date : October 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arm Intervention/treatment
Experimental: 1 Drug: fenofibrate / simvastatin
Combination of fenofibrate and simvastatin 20 mg and 40 mg

Active Comparator: 2 Drug: Atorvastatin
Atorvastatin 10 mg and 20mg




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

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mixed dyslipidemia.

Exclusion Criteria:

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

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): NCT00362934


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Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Martine Guy, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00362934     History of Changes
Other Study ID Numbers: C LF0242780-01 05 03
2006-000519-21
First Posted: August 15, 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 versus atorvastatin

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