Back to resultsInvestigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
Primary Purpose
Hypercholesterolemia, Coronary Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653, ezetimibe
Comparator: ezetimibe, placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Elevated Cholesterol
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092599
Brief Title
Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
The duration of treatment is 10 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Coronary Disease
Keywords
Elevated Cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
410 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0653, ezetimibe
Intervention Type
Drug
Intervention Name(s)
Comparator: ezetimibe, placebo
Primary Outcome Measure Information:
Title
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Secondary Outcome Measure Information:
Title
Safety and tolerability.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15899106
Citation
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. doi: 10.1185/030079905X382004.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
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