CSR Summaries

For interested patients, health care providers and the public, Otsuka provides open access to CSR Summaries from Otsuka-sponsored clinical trials in patients included in applications for regulatory approval filed with the US Food and Drug Administration, the European Medicines Agency and the Japan Pharmaceuticals and Medical Devices Agency on or after January 1, 2014. CSR Summaries are made available consistent with the need to protect privacy, publication rights and commercially confidential information through appropriate redaction.
Postings Description
31-05-243

An Open-Label Rollover Study for Subjects with Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241

31-03-240

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Two Fixed Oral Doses of Aripiprazole (10 mg and 30 mg) in the Treatment of Child and Adolescent Patients, Ages 10-17 Years, with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features

31-03-238

An Open-label Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Aripiprazole Tablets in Children and Adolescent Patients

CN138020

Assessment of the In Vivo Release Characteristics and Safety of an Intramuscular Depot Formulation of Aripiprazole in Subjects with Schizophrenia or Schizoaffective Disorder

CN138014

Tolerability, Pharmacokinetics and Pharmacodynamics of Aripiprazole During Oral Administration in Children and Adolescents with Conduct Disorder

CN138603

Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Subjects with Irritability Associated with Autistic Disorder

CN138180

A 52-Week, Open-label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder

CN138179

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study with Autistic Disorder

CN138178

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder

031-KOA-0703

A Randomized, Double-blind, Dose-adjustment, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aripiprazole in Children and Adolescents with Chronic Tic Disorders or Tourette’s Disorder