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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01381679
First received: June 23, 2011
Last updated: February 17, 2012
Last verified: February 2012

June 23, 2011
February 17, 2012
May 2009
December 2010   (final data collection date for primary outcome measure)
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
Number of participants achieving individual LDL cholesterol target level [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01381679 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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)
Austrian Cholesterol Screening And Treatment II (ACT II)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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)

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1682
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01381679
MK-0653A-205
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP