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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:
ClinicalTrials.gov Identifier:
NCT00088621
First Posted: August 2, 2004
Last Update Posted: April 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
Results First Submitted: February 11, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
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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
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.
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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 
Overall Participants Analyzed 
[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



Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00088621     History of Changes
Other Study ID Numbers: D1050199
First Submitted: July 30, 2004
First Posted: August 2, 2004
Results First Submitted: February 11, 2011
Results First Posted: May 6, 2011
Last Update Posted: April 17, 2014