Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653, ezetimibe / Duration of Treatment: 28 weeks
Comparator: atorvastatin / Duration of Treatment: 28 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria: Elevated cholesterol levels Exclusion Criteria: Liver disease Unstable medical conditions
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092716
Brief Title
Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
655 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0653, ezetimibe / Duration of Treatment: 28 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: atorvastatin / Duration of Treatment: 28 weeks
Primary Outcome Measure Information:
Title
To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
Secondary Outcome Measure Information:
Title
Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
Title
Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elevated cholesterol levels
Exclusion Criteria:
Liver disease
Unstable medical conditions
12. IPD Sharing Statement
Citations:
PubMed Identifier
15194018
Citation
Ballantyne CM, Blazing MA, King TR, Brady WE, Palmisano J. Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia. Am J Cardiol. 2004 Jun 15;93(12):1487-94. doi: 10.1016/j.amjcard.2004.02.060.
Results Reference
background
PubMed Identifier
16369229
Citation
McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3.
Results Reference
background
PubMed Identifier
16004682
Citation
Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30. doi: 10.1185/030079905X50642.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
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