Text Size

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
Results First Received: November 23, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hypercholesterolemia
Intervention: Drug: Ezetimibe

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.

Participant Flow:   Overall Study
    All Participants  
STARTED     1682  
COMPLETED     794  
NOT COMPLETED     888  
Adverse Event                 3  
Lost to Follow-up                 885  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
All Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  1682  
Age  
[units: years]
Mean ± Standard Deviation 		  64.58  ± 10.4  
Gender, Customized  
[units: Participants]
 		 
Males     1003  
Females     655  
Not Reported     24  
Region of Enrollment  
[units: participants]
 		 
Austria     1682  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level   [ Time Frame: Up to 12 months ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Total Cholesterol (TC) at Month 3   [ Time Frame: Baseline and Month 3 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in TC at Month 12   [ Time Frame: Baseline and Month 12 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in LDL-C at Month 3   [ Time Frame: Baseline and Month 3 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in LDL-C at Month 12   [ Time Frame: Baseline and Month 12 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3   [ Time Frame: Baseline and Month 3 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in HDL-C at Month 12   [ Time Frame: Baseline and Month 12 ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Change From Baseline in HDL-C at Month 12
Measure Description No text entered.
Time Frame Baseline and Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.

Reporting Groups
  Description
All Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
 		  774  
Change From Baseline in HDL-C at Month 12  
[units: mg/dL]
Mean ( 95% Confidence Interval ) 		  4.0  
  ( 3.1 to 5.0 )  

No statistical analysis provided for Change From Baseline in HDL-C at Month 12



8.  Secondary:   Change From Baseline in Triglycerides (TG) at Month 3   [ Time Frame: Baseline and Month 3 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in TG at Month 12   [ Time Frame: Baseline and Month 12 ]
  Show Outcome Measure 9


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01381679     History of Changes
Other Study ID Numbers: MK-0653A-205
Study First Received: June 23, 2011
Results First Received: November 23, 2011
Last Updated: February 17, 2012
Health Authority: Austria: Agency for Health and Food Safety