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

NCT00349375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2009-07-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00349375 on ClinicalTrials.gov