A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)

Phase 3

Completed

• Conditions: Hypercholerolemia

• Registration Number: NCT00157911
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-10
• Study Completion: 2003-12
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Korean males or females at least 18 years of age with hypercholesterolemia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LDL-C

Secondary Outcome Measures

Name	Time	Method
TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio