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Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092599
First received: September 23, 2004
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.


Condition Intervention Phase
Hypercholesterolemia
Coronary Disease
Drug: MK0653, ezetimibe
Drug: Comparator: ezetimibe, placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment

Secondary Outcome Measures:
  • Safety and tolerability.

Enrollment: 410
Study Start Date: February 2003
Study Completion Date: July 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 10 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

  • Patients who do not meet specific cholesterol levels as required by the study
  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 ClinicalTrials.gov identifier: NCT00092599

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092599     History of Changes
Other Study ID Numbers: 0653-801, 2004_039
Study First Received: September 23, 2004
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Hypercholesterolemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Ezetimibe
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014