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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01381679
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : March 22, 2012
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Hypercholesterolemia Drug: Ezetimibe

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Study Type : Observational
Actual Enrollment : 1682 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Austrian Cholesterol Screening And Treatment II (ACT II)
Study Start Date : May 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Group/Cohort Intervention/treatment
All participants
Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Drug: Ezetimibe
Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.

Primary Outcome Measures :
  1. 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 :
  1. Change From Baseline in Total Cholesterol (TC) at Month 3 [ Time Frame: Baseline and Month 3 ]
  2. Change From Baseline in TC at Month 12 [ Time Frame: Baseline and Month 12 ]
  3. Change From Baseline in LDL-C at Month 3 [ Time Frame: Baseline and Month 3 ]
  4. Change From Baseline in LDL-C at Month 12 [ Time Frame: Baseline and Month 12 ]
  5. Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 [ Time Frame: Baseline and Month 3 ]
  6. Change From Baseline in HDL-C at Month 12 [ Time Frame: Baseline and Month 12 ]
  7. Change From Baseline in Triglycerides (TG) at Month 3 [ Time Frame: Baseline and Month 3 ]
  8. Change From Baseline in TG at Month 12 [ Time Frame: Baseline and Month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01381679    
Other Study ID Numbers: 0653A-205
First Posted: June 27, 2011    Key Record Dates
Results First Posted: March 22, 2012
Last Update Posted: October 14, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents