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

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.

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Key information

Conditions

Hypercholerolemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

MK0653; ezetimibe / Duration of Treatment: 12 weeks

Drug

Comparator: simvastatin / Duration of Treatment: 12 weeks

Drug

Primary outcomes

LDL-C

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Sep 12, 2005
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed