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)

Hypercholesterolemia Clinical Trial

— ACT II  

Official title:

Austrian Cholesterol Screening And Treatment II (ACT II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381679
• Other study ID #: 0653A-205
• Status: Completed
• Start date: May 2009
• Est. completion date: December 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1682
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Participants in whom LDL-cholesterol target levels have not been achieved.

• Participants in whom a decision has been made by the physician to initiate treatment

with ezetimibe (longitudinal analyses). The treatment decision will be made prior to

and independent from inclusion of participants into this study.

• Participants with LDL cholesterol levels =113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.

Exclusion criteria:

• Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe.

• In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial.

• Previous and ongoing treatment with ezetimibe.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Ezetimibe
Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level	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	Up to 12 months
Secondary	Change From Baseline in Total Cholesterol (TC) at Month 3		Baseline and Month 3
Secondary	Change From Baseline in TC at Month 12		Baseline and Month 12
Secondary	Change From Baseline in LDL-C at Month 3		Baseline and Month 3
Secondary	Change From Baseline in LDL-C at Month 12		Baseline and Month 12
Secondary	Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3		Baseline and Month 3
Secondary	Change From Baseline in HDL-C at Month 12		Baseline and Month 12
Secondary	Change From Baseline in Triglycerides (TG) at Month 3		Baseline and Month 3
Secondary	Change From Baseline in TG at Month 12		Baseline and Month 12