Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3

Primary Measures

• Percent change from baseline to 12 weeks of treatment in TG, HDL-C and LDL-C
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Percent change from baseline in TG, HDL-C, LDL-C, non HDL-C, TC, Apo AI and Apo B; change from baseline in hs CRP and fibrinogen. Percentage of patients reaching the NCEP ATP III target LDL-C and TG levels.
  • Time Frame: 12 and/or 24 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00349375

Study ID Number: C LF0242780-01 05 01

ClinicalTrials.gov Identifier: NCT00349375

Health Authority: France: Afssaps - French Health Products Safety Agency