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Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00652327
First received: March 31, 2008
Last updated: June 24, 2010
Last verified: June 2010
History of Changes
Results First Received: May 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin)
Drug: Double Statin (simvastatin, atorvastatin, or pravastatin)

  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
A total of 202 potential participants signed informed consent during a screening visit. Of these, 119 did not meet protocol eligibility requirements. The remainder, 83, received randomized treatment assignment.

Reporting Groups
  Description
Ezetimibe + Statin Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Double Statin Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks

Participant Flow:   Overall Study
    Ezetimibe + Statin     Double Statin  
STARTED     42 [1]   41 [2]
COMPLETED     42     36  
NOT COMPLETED     0     5  
Adverse Event                 0                 2  
Lost to Follow-up                 0                 3  
[1] Participants who recieved randomized treatment assignment to ezetimibe and ongoing statin
[2] Participants who recieved randomized treatment assignment to double the dose of ongoing statin



  Baseline Characteristics
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Reporting Groups
  Description
Ezetimibe + Statin Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Double Statin Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Ezetimibe + Statin     Double Statin     Total  
Number of Participants  
[units: participants]
 		  42     41     83  
Age, Customized  
[units: Participants]
 		     
<=18 years     0     0     0  
Between 18 and 83 years     42     41     83  
>=83 years     0     0     0  
Gender  
[units: participants]
 		     
Female     19     18     37  
Male     23     23     46  
Region of Enrollment  
[units: Participants]
 		     
Taiwan     42     41     83  



  Outcome Measures

1.  Primary:   Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment   [ Time Frame: Assessed at the end of 8 weeks of treatment (from baseline to endpoint) ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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
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Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided by Schering-Plough

Publications automatically indexed to this study:


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00652327     History of Changes
Other Study ID Numbers: P04355
Study First Received: March 31, 2008
Results First Received: May 12, 2010
Last Updated: June 24, 2010
Health Authority: Taiwan: Department of Health