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Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01190267
First received: August 25, 2010
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: July 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia, Paranoid
Schizophrenia, Disorganized
Schizophrenia, Undifferentiated
Intervention: Drug: asenapine

  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
No text entered.

Reporting Groups
  Description
Asenapine - Participants Who Were ≤17 Years Old In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
Asenapine - Participants Who Were 18 Years Old In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.

Participant Flow:   Overall Study
    Asenapine - Participants Who Were ≤17 Years Old     Asenapine - Participants Who Were 18 Years Old  
STARTED     196     8  
COMPLETED     155     4  
NOT COMPLETED     41     4  
Adverse Event                 10                 0  
Treatment Failure                 8                 2  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 13                 1  
Protocol Violation                 8                 1  



  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.
All participants who received at least one dose of extension study medication

Reporting Groups
  Description
Asenapine - Participants Who Were ≤17 Years Old In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
Asenapine - Participants Who Were 18 Years Old In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
Total Total of all reporting groups

Baseline Measures
    Asenapine - Participants Who Were ≤17 Years Old     Asenapine - Participants Who Were 18 Years Old     Total  
Number of Participants  
[units: participants]
  196     8     204  
Age  
[units: years]
Mean ± Standard Deviation
  15.3  ± 1.5     18  ± 0     15.4  ± 1.6  
Gender  
[units: participants]
     
Female     74     4     78  
Male     122     4     126  



  Outcome Measures
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1.  Primary:   Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study   [ Time Frame: Up to 30 weeks ]

2.  Primary:   Number of Participants Who Discontinued Study Drug During Extension Study Due to an Adverse Event   [ Time Frame: Up to 26 weeks ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01190267     History of Changes
Other Study ID Numbers: P05897, 2009-018038-12, MK-8274-021
Study First Received: August 25, 2010
Results First Received: July 14, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration