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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092716
First received: September 23, 2004
Last updated: May 24, 2013
Last verified: May 2013

September 23, 2004
May 24, 2013
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
Not Provided
Not Provided
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Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)(COMPLETED)
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
700
Not Provided
April 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elevated cholesterol levels

Exclusion Criteria:

  • Liver disease
  • Unstable medical conditions
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092716
2004_047, MK0653-025
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2013

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