Back to resultsA Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)
Primary Purpose
Hypercholerolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653; ezetimibe / Duration of Treatment: 12 weeks
Comparator: simvastatin / Duration of Treatment: 12 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholerolemia
Eligibility Criteria
Inclusion Criteria: Korean males or females at least 18 years of age with hypercholesterolemia
Sites / Locations
Outcomes
Primary Outcome Measures
LDL-C
Secondary Outcome Measures
TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00157911
Brief Title
A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)
Official Title
A Double-Blind, Randomized, Multicenter, Active-Comparative, 12-Week Study to Assess the Efficacy and Safety of the Drug in Conjunction With Another Drug in Korean Patients With Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
December 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
Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholerolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0653; ezetimibe / Duration of Treatment: 12 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: simvastatin / Duration of Treatment: 12 weeks
Primary Outcome Measure Information:
Title
LDL-C
Secondary Outcome Measure Information:
Title
TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Korean males or females at least 18 years of age with hypercholesterolemia
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:
Citation
Bae JW, Kim HS, Lee SC, Han KH, Jeon ES. The safety and efficacy of ezetimibe and simvastatin combination therapy in Korean patients with primary hypercholesterolemia. Korean J Med. 2005;68(5):487-497 [in Korean].
Results Reference
result
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
A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)
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