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

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.

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants Who Receives EZETROL® In Usual Medical Practice

Treatment and study plan

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2010
First posted: Feb 18, 2010
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed