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

Phase 3

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Fenofibrate/Simvastatin; Drug: Simvastatin

• Registration Number: NCT00352183
• Lead Sponsor: 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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Study First Posted: 2006-07-14
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fenofibrate/Simvastatin	-
2	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
Triglycerides	12 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C	12 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline to 24 weeks of treatment in Triglycerides	24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C	24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C	24 weeks

Trial Locations

Locations (67)

Site 204; 🇦🇺 Adelaide, Australia

Site 214; 🇦🇺 Adelaide, Australia

Site 203; 🇦🇺 Bendigo, Australia

Site 207; 🇦🇺 Brisbane, Australia

Site 208; 🇦🇺 Brisbane, Australia

Site 221; 🇦🇺 Brisbane, Australia

Site 202; 🇦🇺 Burnie, Australia

Site 201; 🇦🇺 Camperdown, Australia

Site 220; 🇦🇺 Coffs Harbour, Australia

Site 218; 🇦🇺 Daw Park, Australia

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