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Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00724477
First received: July 25, 2008
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
Results First Received: November 24, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Primary Hypercholesterolemia
Intervention: Drug: INEGY

  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
Subjects Treated With INEGY Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).

Participant Flow:   Overall Study
    Subjects Treated With INEGY  
STARTED     1663 [1]
COMPLETED     1663  
NOT COMPLETED     0  
[1] This safety population (SAF)analysed consisted of all patients who took at least one tablet of INEGY



  Baseline Characteristics
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  Outcome Measures

1.  Primary:   Number of Participants Reaching the Targeted LDL-C Levels   [ Time Frame: 1 to 3 months after starting treatment ]
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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 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.


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


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00724477     History of Changes
Other Study ID Numbers: P05103
Study First Received: July 25, 2008
Results First Received: November 24, 2009
Last Updated: February 3, 2010
Health Authority: France: Commission nationale de l'Informatique et des Libertés