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

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT01070953
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-28
• Results First Submitted QC: 2011-09-26
• Results First Posted: 2011-11-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4467

Inclusion Criteria

• Participants Who Receives EZETROL® In Usual Medical Practice

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation	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	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®	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.