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
31-12-297

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

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)