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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.

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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
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)
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
31-03-241
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
31-05-243
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
31-03-239
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Two Fixed Oral Doses of Aripiprazole (10 mg or 30 mg) in the Treatment of Adolescent Patients with Schizophrenia
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