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

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.
ClinicalTrials.gov Identifier: NCT01070953
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : November 4, 2011
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Hypercholesterolemia

Study Design

Study Type : Observational
Actual Enrollment : 4467 participants
Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice
Study Start Date : January 2005
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
EZETROL® 10 mg
Participants with Hypercholesterolemia treated with EZETROL®


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.

  2. Mean Percent Change From Baseline to Treatment in Lipid Parameters [ Time Frame: Baseline to 4 weeks ]
    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.

  3. Overall Efficacy Evaluation of EZETROL® [ Time Frame: Baseline to 4 weeks ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01070953


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01070953     History of Changes
Other Study ID Numbers: 0653-175
2010_009
First Posted: February 18, 2010    Key Record Dates
Results First Posted: November 4, 2011
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents