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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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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.
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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
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1.  Primary:   Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level   [ Time Frame: Up to 12 months ]

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

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

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

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

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

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

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

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


  Serious Adverse Events
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Time Frame 12 months
Additional Description 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.

Serious Adverse Events
    All Participants  
Total, serious adverse events    
# participants affected / at risk     3/1682 (0.18%)  
Hepatobiliary disorders    
Cholecystitis † 1  
# participants affected / at risk     1/1682 (0.06%)  
# events     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Basal Cell Carcinoma † 1  
# participants affected / at risk     1/1682 (0.06%)  
# events     1  
Bronchial Neoplasm † 1  
# participants affected / at risk     1/1682 (0.06%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1




  Other Adverse Events


  Limitations and Caveats
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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
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  More Information