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Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 21, 2004
Last updated: April 10, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Hypercholesterolemia Drug: MK0733, simvastatin Drug: Comparator: simvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Fasting triglyceride levels at 12 weeks.

Secondary Outcome Measures:
  • 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

Enrollment: 571
Actual Study Start Date: May 1, 2002
Study Completion Date: March 4, 2003
Primary Completion Date: March 3, 2003 (Final data collection date for primary outcome measure)
Detailed Description:
The duration of treatment is 12 weeks.

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elevated cholesterol level

Exclusion Criteria:

  • Liver disease
  • Known allergies to study drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00092157

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092157     History of Changes
Other Study ID Numbers: 0733-224
Study First Received: September 21, 2004
Last Updated: April 10, 2017

Keywords provided by Merck Sharp & Dohme Corp.:
High cholesterol

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 17, 2017