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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01070953
First received: February 17, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition
Hypercholesterolemia

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)
Groups/Cohorts
EZETROL® 10 mg
Participants with Hypercholesterolemia treated with EZETROL®

  Eligibility

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®

Criteria

Inclusion Criteria:

  • Participants Who Receives EZETROL® In Usual Medical Practice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070953

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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.:
Hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 23, 2014