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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00349375
First received: July 6, 2006
Last updated: July 7, 2009
Last verified: July 2009
History of Changes

July 6, 2006
July 7, 2009
November 2005
September 2008   (final data collection date for primary outcome measure)
  • Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
LDL-C, TG, HDL-C
Complete list of historical versions of study NCT00349375 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: Fenofibrate/Simvastatin
    Combination of Fenofibrate 145mg and Simvastatin 20mg
  • Drug: Fenofibrate/Simvastatin
    Combination of Fenofibrate and Simvastatin 40 mg
  • Drug: Simvastatin
    Simvastatin 40 mg
  • Experimental: 1
    Intervention: Drug: Fenofibrate/Simvastatin
  • Experimental: 2
    Intervention: Drug: Fenofibrate/Simvastatin
  • Active Comparator: 3
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1040
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Denmark,   France,   Germany,   Hungary,   Netherlands,   Poland,   Ukraine
 
NCT00349375
C LF0242780-01 05 01, 2005-003270-14
Not Provided
Martine Guy, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP