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Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
This study has been completed.

First Received on July 13, 2006.   Last Updated on July 7, 2009   History of Changes
Sponsor: 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Procetofen Simvastatin
U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 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
Experimental: 1 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40mg
Active Comparator: 2 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: Martine Guy, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00352183     History of Changes
Other Study ID Numbers: C LF0242780-01 05 02, ACTRN012605000777695
Study First Received: July 13, 2006
Last Updated: July 7, 2009
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Fenofibrate
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 13, 2012



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