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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092157
First Posted: September 24, 2004
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Elevated cholesterol level

Exclusion Criteria:

  • Liver disease
  • Known allergies to study drugs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092157


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092157     History of Changes
Other Study ID Numbers: 0733-224
2004_060
First Submitted: September 21, 2004
First Posted: September 24, 2004
Last Update Posted: April 12, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors