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

Tracking Information
First Received Date ^ICMJE	January 29, 2005
Last Updated Date	July 31, 2012
Start Date ^ICMJE	September 2004
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 31, 2012)	Percentage of Subjects Experiencing SAEs [ Time Frame: Baseline and Week 23 ] [ Designated as safety issue: Yes ] Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00102518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 31, 2012)	Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ] Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome. Change in Young Mania Rating Scale (Y-MRS) Total Score [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ] Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Aripiprazole Open-Label, Safety and Tolerability Study
Official Title ^ICMJE	A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Brief Summary	The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Schizophrenia Bipolar Disorder
Intervention ^ICMJE	Drug: Aripiprazole 2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses Other Name: OPC-14597
Study Arm (s)	Experimental: NCT00102063 and NCT00110461 Subjects All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239). Intervention: Drug: Aripiprazole
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	325
Completion Date	February 2007
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode Exclusion Criteria: Patients with a co-morbid serious, uncontrolled systemic illness Patients with a significant risk of committing suicide
Gender	Both
Ages	10 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00102518
Other Study ID Numbers ^ICMJE	31-03-241
Has Data Monitoring Committee	Not Provided
Responsible Party	Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor ^ICMJE	Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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