Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00362206
First received: August 8, 2006
Last updated: July 7, 2009
Last verified: July 2009

August 8, 2006
July 7, 2009
September 2006
September 2008   (final data collection date for primary outcome measure)
  • Percent change from baseline to 12 weeks of treatment in 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 ]
LDL-C, TG, HDL-C
Complete list of historical versions of study NCT00362206 on ClinicalTrials.gov Archive Site
  • Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 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 Simvastatin Versus Pravastatin
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

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.

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 and Simvastatin 20mg
  • Drug: Fenofibrate/Simvastatin
    Combination of Fenofibrate and Simvastatin 40 mg
  • Drug: Pravastatin
    Pravastatin 40 mg
  • Experimental: 1
    Intervention: Drug: Fenofibrate/Simvastatin
  • Experimental: 2
    Intervention: Drug: Fenofibrate/Simvastatin
  • Active Comparator: 3
    Intervention: Drug: Pravastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
423
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Israel,   Romania,   Russian Federation,   South Africa
 
NCT00362206
C LF0242780-01 05 04, 2006-000515-15
No
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