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) (ACT II)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: June 27, 2011
Last Update Posted: October 14, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Austrian Cholesterol Screening And Treatment II (ACT II)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level [ Time Frame: 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:
- Change From Baseline in Total Cholesterol (TC) at Month 3 [ Time Frame: Baseline and Month 3 ]
- Change From Baseline in TC at Month 12 [ Time Frame: Baseline and Month 12 ]
- Change From Baseline in LDL-C at Month 3 [ Time Frame: Baseline and Month 3 ]
- Change From Baseline in LDL-C at Month 12 [ Time Frame: Baseline and Month 12 ]
- Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 [ Time Frame: Baseline and Month 3 ]
- Change From Baseline in HDL-C at Month 12 [ Time Frame: Baseline and Month 12 ]
- Change From Baseline in Triglycerides (TG) at Month 3 [ Time Frame: Baseline and Month 3 ]
- Change From Baseline in TG at Month 12 [ Time Frame: Baseline and Month 12 ]
|Study Start Date:||May 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.
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