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Aripiprazole Open-Label, Safety and Tolerability Study (APEX 241)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00102518
First received: January 29, 2005
Last updated: July 31, 2012
Last verified: July 2012
Results First Received: May 16, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Bipolar Disorder
Intervention: Drug: Aripiprazole

  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
Participants were recruited from 157 centers in Argentina, Bulgaria, Croatia, India, Jamaica, Mexico, Romania, Russia, Serbia, South Africa, South Korea, Ukraine, and the United States between September 2004 and February 2007. A total of 325 subjects were screened for enrollment and all 325 subjects were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants had previously completed NCT00102063 (OPDC 31-03-239, adolescents with schizophrenia) or had withdrawn from the double-blind extension phase of NCT00110461 (OPDC 31-03-240, children and adolescents with bipolar 1 disorder), both clinical studies of aripiprazole.

Reporting Groups
  Description
NCT00102063 and NCT00110461 Subjects All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.

Participant Flow:   Overall Study
    NCT00102063 and NCT00110461 Subjects  
STARTED     325  
COMPLETED     238  
NOT COMPLETED     87  



  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
NCT00102063 and NCT00110461 Subjects All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.

Baseline Measures
    NCT00102063 and NCT00110461 Subjects  
Number of Participants  
[units: participants]
  325  
Age  
[units: years]
Mean ± Standard Deviation
  15.02  ± 1.89  
Gender  
[units: participants]
 
Female     140  
Male     185  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     44  
Not Hispanic or Latino     281  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     34  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     38  
White     206  
More than one race     45  
Unknown or Not Reported     0  
Height  
[units: cm]
Mean ± Standard Deviation
  164.09  ± 11.22  
Weight  
[units: kg]
Mean ± Standard Deviation
  63.19  ± 17.86  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  23.25  ± 5.21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects Experiencing SAEs   [ Time Frame: Baseline and Week 23 ]

2.  Secondary:   Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Baseline and Week 26 ]

3.  Secondary:   Change in Young Mania Rating Scale (Y-MRS) Total Score   [ Time Frame: Baseline and Week 26 ]


  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: Margaretta Nyilas
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
phone: 609-452-5673
e-mail: Margaretta.nyilas@otsuka-us.com


No publications provided


Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00102518     History of Changes
Other Study ID Numbers: 31-03-241
Study First Received: January 29, 2005
Results First Received: May 16, 2012
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration