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Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00909389
First received: May 20, 2009
Last updated: May 6, 2014
Last verified: May 2014
Results First Received: June 24, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hypercholesterolemia
Intervention: Drug: Vytorin (R) (Ezetimibe + Simvastatin)

  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
No text entered.

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
Filipino Patients With Hypercholesterolemia No text entered.

Participant Flow:   Overall Study
    Filipino Patients With Hypercholesterolemia  
STARTED     4748  
COMPLETED     4615  
NOT COMPLETED     133  
Adverse Event                 6  
Death                 4  
Poor Compliance                 16  
Lost to Follow-up                 4  
No Information                 103  



  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
Filipino Patients With Hypercholesterolemia No text entered.

Baseline Measures
    Filipino Patients With Hypercholesterolemia  
Number of Participants  
[units: participants]
  4748  
Age  
[units: years]
Mean ± Standard Deviation
  55.53  ± 11.71  
Gender  
[units: participants]
 
Female     2400  
Male     2348  



  Outcome Measures

1.  Primary:   Number of Participants Who Had an Adverse Event (AE).   [ Time Frame: Throughout study up to Day 29 (Final Visit) ]


  Serious Adverse Events


  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
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00909389     History of Changes
Other Study ID Numbers: P05647
Study First Received: May 20, 2009
Results First Received: June 24, 2009
Last Updated: May 6, 2014
Health Authority: Philippines: Bureau of Food and Drugs