A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia

This study is ongoing, but not recruiting participants.

First Received: September 7, 2005 Last Updated: October 25, 2005 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00157911

Purpose

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.

Condition	Intervention	Phase
Hypercholerolemia	Drug: MK0653; ezetimibe / Duration of Treatment: 12 weeks Drug: Comparator: simvastatin / Duration of Treatment: 12 weeks	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

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

Estimated Enrollment:	136
Study Start Date:	December 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157911

Locations

Korea, Republic of
MSD Korea Ltd.
Seoul, Korea, Republic of, 121-705

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2005_065
Study First Received:	September 7, 2005
Last Updated:	October 25, 2005
ClinicalTrials.gov Identifier:	NCT00157911 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Simvastatin
Antilipemic Agents
Ezetimibe

Anticholesteremic Agents
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Ezetimibe
Anticholesteremic Agents
Hypercholesterolemia
Pharmacologic Actions
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009