An Open-Label Rollover Study for Subjects with Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241
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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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
An Open-label Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Aripiprazole Tablets in Children and Adolescent Patients
Assessment of the In Vivo Release Characteristics and Safety of an Intramuscular Depot Formulation of Aripiprazole in Subjects with Schizophrenia or Schizoaffective Disorder
Tolerability, Pharmacokinetics and Pharmacodynamics of Aripiprazole During Oral Administration in Children and Adolescents with Conduct Disorder
Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Subjects with Irritability Associated with Autistic Disorder
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
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study with Autistic Disorder
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
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
A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia
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
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
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
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
Multicenter Open-label Study Investigating the Pharmacokinetics of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration to Patients with Schizophrenia
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
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
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)
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)