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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CN138014

Tolerability, Pharmacokinetics and Pharmacodynamics of Aripiprazole During Oral Administration in Children and Adolescents with Conduct Disorder

CN138603

Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Subjects with Irritability Associated with Autistic Disorder

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

CN138020

Assessment of the In Vivo Release Characteristics and Safety of an Intramuscular Depot Formulation of Aripiprazole in Subjects with Schizophrenia or Schizoaffective Disorder

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

31-05-244

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

31-09-268

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

31-05-243

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

31-03-238

An Open-label Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Aripiprazole Tablets in Children and Adolescent Patients