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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157911
First Posted: September 12, 2005
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 136
Study Start Date: December 2002
Study Completion Date: December 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Korean males or females at least 18 years of age with hypercholesterolemia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157911


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
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].

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157911     History of Changes
Other Study ID Numbers: 0653-042
MK0653-042
2005_065
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors