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A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00088621
First received: July 30, 2004
Last updated: March 31, 2014
Last verified: March 2014
Results First Received: February 11, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Lurasidone 80mg tablet

  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
Lurasidone 80 mg Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.

Participant Flow:   Overall Study
    Lurasidone 80 mg  
STARTED     61  
COMPLETED     7  
NOT COMPLETED     54  



  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
Lurasidone 80 mg Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.

Baseline Measures
    Lurasidone 80 mg  
Number of Participants  
[units: participants]
  59  
Age  
[units: years]
Mean ± Standard Deviation
  41.3  ± 11.05  
Gender  
[units: participants]
 
Female     15  
Male     44  
Region of Enrollment  
[units: participants]
 
United States     59  



  Outcome Measures

1.  Primary:   Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study   [ Time Frame: 1 year ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Josephine Cucchiaro, Executive Director
Organization: Sunovion
phone: 201-592-2050
e-mail: josephine.cucchiaro@sunovion.com


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00088621     History of Changes
Other Study ID Numbers: D1050199
Study First Received: July 30, 2004
Results First Received: February 11, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration