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

History of Changes

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

Hide Participant Flow

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All participants had previously completed NCT00102063 (OPDC 31-03-239, adolescents with schizophrenia) or had withdrawn from the double-blind extension phase of NCT00110461 (OPDC 31-03-240, children and adolescents with bipolar 1 disorder), both clinical studies of aripiprazole.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NCT00102063 and NCT00110461 Subjects	All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.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

Hide Baseline Characteristics

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NCT00102063 and NCT00110461 Subjects	All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

Limitations and Caveats

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
No text entered.

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

To Top