Effectiveness of Two Approved Drugs in Lowering High Cholesterol
Information source: Merck
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: MK0733, simvastatin (Drug); Comparator: simvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck
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.
Clinical Details
Official title: 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)
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Fasting triglyceride levels at 12 weeks.
Secondary outcome: 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
Detailed description:
The duration of treatment is 12 weeks.
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Elevated cholesterol level
Exclusion Criteria:
- Liver disease
- Known allergies to study drugs
Locations and Contacts
Additional Information
Related publications: Grundy SM, Vega GL, Yuan Z, Battisti WP, Brady WE, Palmisano J. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am J Cardiol. 2005 Feb 15;95(4):462-8.
Starting date: May 2002
Last updated: May 17, 2006
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