Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00145496
First received: September 1, 2005
Last updated: September 25, 2014
Last verified: September 2014
Results First Received: March 5, 2010  
Study Type: Interventional
Study Design: Allocation: 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
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
Asenapine 5-10 mg sublingually twice daily for up to 26 weeks
Olanzapine 5-20 mg by mouth once daily for up to 26 weeks

Participant Flow:   Overall Study
    Asenapine     Olanzapine  
STARTED     244 [1]   224 [1]
COMPLETED     121     143  
NOT COMPLETED     123     81  
Adverse Event                 42                 30  
Lack of Efficacy                 12                 7  
Withdrawal by Subject                 32                 26  
Lost to Follow-up                 12                 5  
Other                 25                 13  
[1] Subjects who received randomized treatment assignment and at least one dose of study medication.



  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
Asenapine 5-10 mg sublingually twice daily for up to 26 weeks
Olanzapine 5-20 mg by mouth once daily for up to 26 weeks
Total Total of all reporting groups

Baseline Measures
    Asenapine     Olanzapine     Total  
Number of Participants  
[units: participants]
  244     224     468  
Age  
[units: years]
Mean ± Standard Deviation
  43.1  ± 11.43     42.8  ± 11.27     42.9  ± 11.34  
Age, Customized  
[units: participants]
     
<18 years     0     0     0  
18 to 64 years     239     217     456  
>=65 years     5     7     12  
Gender  
[units: participants]
     
Female     68     54     122  
Male     176     170     346  
Study-Specific Measure  
[units: kg]
Mean ± Standard Deviation
  84.0  ± 19.01     85.7  ± 18.71     84.8  ± 18.86  



  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: Day 182 ]

2.  Secondary:   Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score   [ Time Frame: Day 182 ]

3.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Day 182 ]


  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, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00145496     History of Changes
Other Study ID Numbers: P05771, Aphrodite, A7501013
Study First Received: September 1, 2005
Results First Received: March 5, 2010
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration