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
31-11-284

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
31-10-002

Multicenter Open-label Study Investigating the Pharmacokinetics of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration to Patients with Schizophrenia
31-09-268

An Open-label, Multi-center, Two Phase, Sequential Design, Single and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of an Extended Release Once-weekly Oral Formulation and an Enteric Coated Extended Release Once-weekly Oral Formulation of Aripiprazole Administered to Children and Adolescents with Tourette’s Disorder
31-09-265

An Open-label, Multi-center, Three Phase, Sequential Design, Single and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of an Enteric Coated Once-weekly Oral Formulation of Aripiprazole Administered to Children and Adolescents with Tourette’s Disorder
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)
31-05-244

An Open-label, Parallel Arm, Multiple Dose Tolerability, Pharmacokinetics and Safety Study in Adult Patients with Schizophrenia Following Administration of Aripiprazole Intramuscular (IM) Depot Formulation Once Every Four Weeks
31-05-243

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