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Study List

The list will generally include Phase 2 and Phase 3 studies that were filed by Otsuka on or after January 1, 2014 as a part of regulatory submissions to medicines regulatory agencies in the US, EU, and Japan, and for which the relevant drug and indication(s) subsequently were granted regulatory approval. Otsuka may list clinical studies outside this scope.

Clinical studies will be listed after completion of regulatory reviews and decisions.

  • In cases when Otsuka seeks regulatory approval in both the US and EU, the list contains entries for dedicated studies for these jurisdictions following approval in both jurisdictions.
  • In cases when Otsuka is not seeking approval in both the US and the EU, clinical studies will be added to the list after approval in a single jurisdiction.
  • In cases when Otsuka seeks approval in the US, EU and Japan based on global studies, such studies will be added after approval in the US, EU and Japan.

Also, the list may include clinical studies conducted in Japan and filed with the PMDA in Japan on or after January 1, 2014 when approval only in Japan is sought.

For existing and past clinical studies, patient informed consent forms do not allow further research beyond the relevant medicine and the disease that were studied in the original studies and may not allow third-party data sharing. Therefore, patient-level data can be shared only when the aims of the research request fall within the scope of the original research, and the informed consent allows access to third-parties.

Researchers who wish to inquire about availability of datasets and documents from studies not listed in this table can do so via Contact Us.

Active Ingredient/Drug Formulation Disease Study ID Study Phase Study Title
Arpiprazole/Oral Schizophrenia 31-03-239 Phase 3 Aripiprazole in Adolescents With Schizophrenia (APEX 239)
Arpiprazole/Oral Bipolar I 31-03-240 Phase 3 Aripiprazole in Children and Adolescents With Bipolar I Disorder
Aripiprazole/Intramuscular Schizophrenia 31-07-246 Phase 3 A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Aripiprazole/Intramuscular Schizophrenia 31-07-247 Phase 3 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
Aripiprazole/Intramuscular Schizophrenia 31-12-291 Phase 3 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
Aripiprazole/Oral Tourette's Disorder 31-12-293 Phase 3 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
Aripiprazole/Oral Tourette's Disorder 031-KOA-0703 Phase 3 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
Aripiprazole/Oral Autistic Disorder CN138-178 Phase 3 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 (AD)
Aripiprazole/Oral Autistic Disorder CN138-179 Phase 3 A Multicenter Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Aripiprazole/Oral Autistic Disorder CN138-603 Phase 3 Safety and Efficacy of Aripiprazole in the Long-term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder
Aripiprazole/Intramuscular Schizophrenia 31-07-246 Phase 3 A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Aripiprazole/Intramuscular Schizophrenia 31-07-247 Phase 3 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
Aripiprazole/Oral Schizophrenia CN138-001 Phase 3 A Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Three Fixed Doses of Aripiprazole in the Trearment of Patients With Acute Schizophrenia



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