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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092599
First Posted: September 27, 2004
Last Update Posted: March 13, 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.
September 23, 2004
September 27, 2004
March 13, 2017
February 2003
June 2004   (Final data collection date for primary outcome measure)
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Not Provided
Complete list of historical versions of study NCT00092599 on ClinicalTrials.gov Archive Site
Safety and tolerability.
Not Provided
Not Provided
Not Provided
 
Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
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.
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.
The duration of treatment is 10 weeks.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Coronary Disease
  • Drug: MK0653, ezetimibe
  • Drug: Comparator: ezetimibe, placebo
Not Provided
Brohet C, Banai S, Alings AM, Massaad R, Davies MJ, Allen C. LDL-C goal attainment with the addition of ezetimibe to ongoing simvastatin treatment in coronary heart disease patients with hypercholesterolemia. Curr Med Res Opin. 2005 Apr;21(4):571-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
July 2004
June 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00092599
0653-801
2004_039
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP