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

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ClinicalTrials.gov Identifier: NCT00092157
Recruitment Status : Completed
First Posted : September 24, 2004
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: MK0733, simvastatin Drug: Comparator: simvastatin Phase 3

Detailed Description:
The duration of treatment is 12 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
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)
Actual Study Start Date : May 1, 2002
Actual Primary Completion Date : March 3, 2003
Actual Study Completion Date : March 4, 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin




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

Secondary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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

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.

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092157     History of Changes
Other Study ID Numbers: 0733-224
2004_060
First Posted: September 24, 2004    Key Record Dates
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