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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157911

Enrollment

136

Registered

2005-09-12

Start date

2002-12-31

Completion date

2003-12-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholerolemia

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.

Interventions

DRUGMK0653; ezetimibe / Duration of Treatment: 12 weeks

DRUGComparator: simvastatin / Duration of Treatment: 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
LDL-C	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026