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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

January 29, 2005
July 31, 2012
September 2004
February 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00102518 on ClinicalTrials.gov Archive Site
  • 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).

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Aripiprazole Open-Label, Safety and Tolerability Study
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Bipolar Disorder
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102518
31-03-241
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP