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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070953
• Other study ID #: 0653-175
• Secondary ID: 2010_009
• Status: Completed
• Start date: January 2005
• Est. completion date: July 2010

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4467
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Participants Who Receives EZETROL® In Usual Medical Practice

Related Conditions & MeSH terms

• Hypercholesterolemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation	Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.	Up to 14 days after treatment discontinuation
Primary	Mean Percent Change From Baseline to Treatment in Lipid Parameters	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.	Baseline to 4 weeks
Primary	Overall Efficacy Evaluation of EZETROL®	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.	Baseline to 4 weeks