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 Sort ascending | Description |
|---|---|
| 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 |
| 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 |
| 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 |