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Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092716
First Posted: September 28, 2004
Last Update Posted: March 1, 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 28, 2004
March 1, 2017
May 2002
April 2003   (Final data collection date for primary outcome measure)
To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
Not Provided
Complete list of historical versions of study NCT00092716 on ClinicalTrials.gov Archive Site
  • Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
  • Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level
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Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia
The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: MK0653, ezetimibe / Duration of Treatment: 28 weeks
  • Drug: Comparator: atorvastatin / Duration of Treatment: 28 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
655
April 2003
April 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elevated cholesterol levels

Exclusion Criteria:

  • Liver disease
  • Unstable medical conditions
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00092716
0653-025
2004_047
Not Provided
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2017

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