Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Ezetimibe

• Registration Number: NCT01381679
• Lead Sponsor: Organon and Co

Brief Summary

This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels \<100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Results First Submitted: 2011-11-23
• Results First Submitted QC: 2012-02-17
• Results First Posted: 2012-03-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1682

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Ezetimibe	Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen.

Primary Outcome Measures

Name	Time	Method
Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level	Up to 12 months	Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in LDL-C at Month 12	Baseline and Month 12
Change From Baseline in Total Cholesterol (TC) at Month 3	Baseline and Month 3
Change From Baseline in LDL-C at Month 3	Baseline and Month 3
Change From Baseline in TC at Month 12	Baseline and Month 12
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3	Baseline and Month 3
Change From Baseline in HDL-C at Month 12	Baseline and Month 12
Change From Baseline in Triglycerides (TG) at Month 3	Baseline and Month 3
Change From Baseline in TG at Month 12	Baseline and Month 12