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

NCT ID: NCT00157911

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Hypercholerolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0653; ezetimibe / Duration of Treatment: 12 weeks

Intervention Type DRUG

Comparator: simvastatin / Duration of Treatment: 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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].

Reference Type RESULT

Other Identifiers

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MK0653-042

Identifier Type: -

Identifier Source: secondary_id

2005_065

Identifier Type: -

Identifier Source: secondary_id

0653-042

Identifier Type: -

Identifier Source: org_study_id

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