To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00150176
First received: September 2, 2005
Last updated: January 7, 2014
Last verified: January 2014
Results First Received: April 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Asenapine - Open Label
Drug: Placebo - Double Blind
Drug: Asenapine - Double Blind

  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
Prior to randomization, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). Only subjects who had continued stable presentation of symptoms during this phase were randomized into the double-blind phase.

Reporting Groups
  Description
Asenapine Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
Placebo Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.

Participant Flow:   Overall Study
    Asenapine     Placebo  
STARTED     194 [1]   192 [1]
COMPLETED     135     72  
NOT COMPLETED     59     120  
Adverse Event                 16                 53  
Relapse/Impending relapse, non-AE                 10                 39  
Withdrawal by Subject                 19                 12  
Lost to Follow-up                 3                 3  
OTHER                 11                 13  
[1] subjects who were screened and received at least one dose of double-blind trial 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.
No text entered.

Reporting Groups
  Description
Asenapine Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
Placebo Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Total Total of all reporting groups

Baseline Measures
    Asenapine     Placebo     Total  
Number of Participants  
[units: participants]
  194     192     386  
Age  
[units: years]
Mean ± Standard Deviation
  39.2  ± 12.53     38.7  ± 11.64     38.9  ± 12.08  
Gender  
[units: participants]
     
Female     89     76     165  
Male     105     116     221  



  Outcome Measures
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1.  Primary:   Time to Relapse or an Impending Relapse   [ Time Frame: time of first relapse up to Day 182 (double blind phase) ]

2.  Secondary:   Time to Early Discontinuation for Any Reason   [ Time Frame: time of discontinuation up to Day 182 (double blind phase) ]


  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


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00150176     History of Changes
Other Study ID Numbers: P05770, A7501012
Study First Received: September 2, 2005
Results First Received: April 28, 2010
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration