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.
Featured Postings

23 Results:


Postings Description
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
31-12-297

A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia
31-07-247

A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Schizophrenia “ASPIRE EU” (Aripiprazole Intramuscular Depot Program in Schizophrenia)
31-07-246

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Schizophrenia “ASPIRE US” Aripiprazole Intramuscular Depot Program in Schizophrenia)
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
31-03-241

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
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
CN138179

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study with Autistic Disorder
31-11-284

A Multicenter, Open-label Study to Assess Hospitalization Rates in Adult Subjects with Schizophrenia Treated Prospectively for 6 Months with Aripiprazole IM Depot Compared With 6-month Retrospective Treatment with Oral Antipsychotics in a Naturalistic Community Setting in Europe, Canada, and Asia
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