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Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)

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. Identifier: NCT00092612
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Coronary Disease Drug: MK0653, ezetimibe Drug: Comparator: ezetimibe, placebo Phase 3

Detailed Description:
The duration of treatment is 10 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.
Study Start Date : May 2003
Primary Completion Date : June 2004
Study Completion Date : June 2004

Primary Outcome Measures :
  1. Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment

Secondary Outcome Measures :
  1. Safety and tolerability.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

  • Patients who have cholesterol levels within normal ranges as identified by the study

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 identifier (NCT number): NCT00092612

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

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092612     History of Changes
Other Study ID Numbers: 0653-802
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Elevated Cholesterol

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents