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6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00174265
First received: September 9, 2005
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
Results First Received: May 27, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: asenapine
Drug: olanzapine

  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
Asenapine 5-10 mg sublingually twice daily for 26 weeks
Olanzapine 5-20 mg by mouth once daily for 26 weeks

Participant Flow:   Overall Study
    Asenapine     Olanzapine  
STARTED     86 [1]   110  
COMPLETED     57     89  
NOT COMPLETED     29     21  
Adverse Event                 7                 4  
Lack of Efficacy                 2                 2  
Withdrawal by Subject                 3                 5  
Lost to Follow-up                 1                 0  
Other (Not specified)                 16                 10  
[1] 85 participants received randomized treatment assignment and at least one dose of study medication.



  Baseline Characteristics
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Reporting Groups
  Description
Asenapine 5-10 mg sublingually twice daily for 26 weeks
Olanzapine 5-20 mg by mouth once daily for 26 weeks
Total Total of all reporting groups

Baseline Measures
    Asenapine     Olanzapine     Total  
Number of Participants  
[units: participants]
 		  85     110     195  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     84     108     192  
>=65 years     1     2     3  
Gender  
[units: participants]
 		     
Female     18     27     45  
Male     67     83     150  



  Outcome Measures
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1.  Primary:   Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score   [ Time Frame: Baseline of A7501013 to Day 365 ]
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2.  Secondary:   Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score   [ Time Frame: Baseline of A7501013 to Day 365 ]
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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: NCT00174265     History of Changes
Other Study ID Numbers: A7501014, Aphrodite;, P05772
Study First Received: September 9, 2005
Results First Received: May 27, 2010
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration