EZETROL® Re-examination Study (MK0653-175)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: February 17, 2010
Last updated: September 26, 2011
Last verified: September 2011

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety information according to the Re-examination Regulation for New Drugs.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation [ Time Frame: Up to 14 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
    Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.

  • Mean Percent Change From Baseline to Treatment in Lipid Parameters [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.

  • Overall Efficacy Evaluation of EZETROL® [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.

Enrollment: 4467
Study Start Date: January 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
EZETROL® 10 mg
Participants with Hypercholesterolemia treated with EZETROL®


Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants with Hypercholesterolemia treated with EZETROL®


Inclusion Criteria:

  • Participants Who Receives EZETROL® In Usual Medical Practice
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070953

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01070953     History of Changes
Other Study ID Numbers: MK-0653-175, 2010_009
Study First Received: February 17, 2010
Results First Received: July 28, 2011
Last Updated: September 26, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014