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.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01381679

First received: June 23, 2011

Last updated: February 17, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 23, 2011
Last Updated Date	February 17, 2012
Start Date ^ICMJE	May 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 17, 2012)	Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE (submitted: June 24, 2011)	Number of participants achieving individual LDL cholesterol target level [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01381679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 17, 2012)	Change From Baseline in Total Cholesterol (TC) at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ] Change From Baseline in TC at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ] Change From Baseline in LDL-C at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ] Change From Baseline in LDL-C at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ] Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ] Change From Baseline in HDL-C at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ] Change From Baseline in Triglycerides (TG) at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ] Change From Baseline in TG at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 24, 2011)	Change in total cholesterol (TC) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ] Change in TC [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ] Change in LDL-C [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ] Change in LDL-C [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ] Change in high-density lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ] Change in HDL-C [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ] Change in triglycerides (TG) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ] Change in TG [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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)
Official Title ^ICMJE	Austrian Cholesterol Screening And Treatment II (ACT II)
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Participants without adequate LDL-cholesterol reduction with a statin, representative cross-section across all regions/parts of Austria (federal provinces, urban/rural areas, office-based internists/general practitioners)
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	Drug: Ezetimibe Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.
Study Group/Cohort (s)	All participants Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen. Intervention: Drug: Ezetimibe
Publications *	Eber B, Lautsch D, Fauer C, Drexel H, Pfeiffer KP, Traindl O, Pichler M. Can LDL-cholesterol targets be achieved in a population at high risk? Results of the non-interventional study ACT II. Curr Med Res Opin. 2012 Sep;28(9):1447-54. Epub 2012 Aug 16.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1682
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01381679
Other Study ID Numbers ^ICMJE	MK-0653A-205
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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