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 Sort ascending Description
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

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

31-12-297

A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia

31-12-293

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder

31-12-291

A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults with Schizophrenia

31-11-289

An Open-label, Safety and Tolerability Trial of Aripiprazole IM Depot Treatment Initiation in Adult Subjects with Schizophrenia Stabilized on Atypical Oral Antipsychotics Other Than Aripiprazole