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Clinical Trials/NCT00092157
NCT00092157
Completed
Phase 3

A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patients With Combined Hyperlipidemia-Simvastatin and Fenofibrate Efficacy Trial (SAFARI)

Organon and Co0 sites571 target enrollmentMay 1, 2002
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ConditionsHypercholesterolemia
DrugsMK0733, simvastatinComparator: simvastatin

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hypercholesterolemia
Sponsor
Organon and Co
Enrollment
571
Primary Endpoint
Fasting triglyceride levels at 12 weeks.
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.

Detailed Description

The duration of treatment is 12 weeks.

Registry
clinicaltrials.gov
Start Date
May 1, 2002
End Date
March 4, 2003
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Elevated cholesterol level

Exclusion Criteria

  • •Liver disease
  • •Known allergies to study drugs

Outcomes

Primary Outcomes

Fasting triglyceride levels at 12 weeks.

Secondary Outcomes

  • Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin

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