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40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00159783
First received: September 8, 2005
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: April 15, 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: Bipolar Disorder
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
Placebo/Asenapine Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
Asenapine Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
Olanzapine Olanzapine 5-20 mg once daily for 40 weeks

Participant Flow:   Overall Study
    Placebo/Asenapine     Asenapine     Olanzapine  
STARTED     32     79     107  
COMPLETED     13     52     68  
NOT COMPLETED     19     27     39  
Adverse Event                 5                 7                 9  
Lack of Efficacy                 1                 2                 3  
Withdrawal by Subject                 7                 11                 12  
Lost to Follow-up                 6                 5                 11  
not specified                 0                 2                 4  



  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
Placebo/Asenapine Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
Asenapine Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
Olanzapine Olanzapine 5-20 mg once daily for 40 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo/Asenapine     Asenapine     Olanzapine     Total  
Number of Participants  
[units: participants]
  32     79     107     218  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     31     77     106     214  
>=65 years     1     2     1     4  
Gender  
[units: participants]
       
Female     15     43     39     97  
Male     17     36     68     121  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participants Who Experienced Adverse Event(s)   [ Time Frame: Up to 40 weeks ]

2.  Primary:   Number of Participants With Abnormal Physical Examination Findings   [ Time Frame: Week 40 or endpoint ]

3.  Primary:   Number of Participants With Abnormal Electrocardiogram   [ Time Frame: Week 40 or endpoint ]

4.  Primary:   Body Weight   [ Time Frame: Baseline to Week 40 or endpoint ]

5.  Primary:   Extrapyramidal Symptoms [EPS]   [ Time Frame: Week 40 or endpoint ]

6.  Primary:   Concomitant Medications   [ Time Frame: Up to 40 weeks ]

7.  Primary:   Abdominal Girth   [ Time Frame: Baseline to Week 40 or endpoint ]

8.  Primary:   Number of Participants With Markedly Abnormal Vital Sign Changes   [ Time Frame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint) ]

9.  Primary:   Number of Participants With Laboratory Values Outside Normal Range   [ Time Frame: Week 40 or endpoint ]


  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.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00159783     History of Changes
Other Study ID Numbers: P05857, A7501007
Study First Received: September 8, 2005
Results First Received: April 15, 2010
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration