Vytorin Reexamination Study (0653A-174)

Completed

• Conditions: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

• Registration Number: NCT01070966
• Lead Sponsor: Organon and Co

Brief Summary

This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-14
• Results First Submitted QC: 2011-04-14
• Results First Posted: 2011-05-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2089

Inclusion Criteria

• Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline to Treatment in Lipid Parameters	Baseline and up to 5 years	The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides\[TG\]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.
Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation	Up to 14 days after the treatment discontinuation	Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.