Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Study Evaluating the of OPC-34712 in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects
The purpose of this study is to evaluate how much of the investigational product gets into the blood stream and how long the body takes to get rid of it when given to subjects with a range of liver impairment compared to subjects…
- Trial name
- NCT01299454
- Testing
- OPC-34712
- Where
- 3 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute…
- Trial name
- STEP 203 (NCT00905307)
- Testing
- OPC-34712, Aripiprazole
- Where
- 73 sites in United States, Bulgaria and 10 more
- Volunteers
- 459 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder, Tic Disorder
Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01727713
- Testing
- Aripiprazole
- Where
- 33 sites in United States, Canada and 2 more
- Volunteers
- 110 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia
The primary objective of the study was to determine the safety of aripiprazole administered long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects with chronic or first episode of schizophrenia.
- Trial name
- NCT02435836
- Testing
- Aripiprazole
- Volunteers
- 631 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Mental Disorder
Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia
- Conditions
- Schizophrenia, Mental Disorder, Nervous System Diseases
- Trial name
- NCT01909466
- Testing
- Aripiprazole, OPC-14597
- Where
- 11 sites in United States
- Volunteers
- 141 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
- Trial name
- ARRIVE US (NCT01432444)
- Testing
- Aripiprazole (Abilify®) IM Depot Injection
- Where
- 124 sites in United States, Canada
- Volunteers
- 493 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar 1 Disorder, Schizophrenia
Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder
The purpose of this study is to evaluate adherence to treatment with, and safety and tolerability of, the medical information device #1 (MIND1) system in subjects with Schizophrenia or Bipolar I Disorder who are currently treated…
- Conditions
- Bipolar 1 Disorder, Schizophrenia, Mental Disorder, Nervous System Diseases
- Trial name
- NCT01981811
- Testing
- Aripiprazole, Ingestible Event Marker (IEM)
- Where
- 12 sites in United States
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a…
- Trial name
- ATTAIN 266 (NCT01149655)
- Testing
- Aripiprazole
- Where
- 52 sites in United States, India and 5 more
- Volunteers
- 252 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute…
- Trial name
- NCT01683058
- Testing
- Aripiprazole IM Depot
- Where
- 38 sites in United States, Croatia and 1 more
- Volunteers
- 74 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
- Trial name
- ARRIVE- EU (NCT01509053)
- Testing
- Aripiprazole (Abilify®) IM Depot Injection, Oral aripiprazole
- Where
- 10 sites in Belgium, Bulgaria and 1 more
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia.
- Trial name
- NCT01663532
- Testing
- Aripiprazole IM Depot
- Where
- 49 sites in United States, Croatia and 1 more
- Volunteers
- 340 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder, Tic Disorder
Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01727700
- Testing
- Aripiprazole
- Where
- 75 sites in United States, Canada and 7 more
- Volunteers
- 133 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.
- Trial name
- NCT00239356
- Testing
- Aripiprazole
- Where
- 20 sites in Canada, Croatia and 9 more
- Volunteers
- 119 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.
- Trial name
- ASPIRE (NCT00731549)
- Testing
- Aripiprazole IM Depot
- Where
- 214 sites in United States, Argentina and 26 more
- Volunteers
- 1,081 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia, Dilutional Hyponatremia
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction.
- Conditions
- Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
- Trial name
- SALACIA (NCT01227512)
- Testing
- tolvaptan, Fluid Restriction
- Where
- 56 sites in United States
- Volunteers
- 124 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole
This study will test the safety of an aripiprazole injection in subjects with schizophrenia that are currently taking oral antipsychotic medication other than aripiprazole.
- Trial name
- NCT01552772
- Testing
- Aripiprazole IM Depot
- Where
- 12 sites in United States
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Lymphoma
PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.
- Trial name
- NCT00948090
- Testing
- IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
- Where
- 42 sites in United States, Canada
- Volunteers
- 207 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia
The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body
- Trial name
- NCT01646827
- Testing
- Aripiprazole IM Depot
- Where
- 6 sites in United States
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar 1 Disorder, Schizophrenia
Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia
The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole.
- Conditions
- Bipolar 1 Disorder, Schizophrenia, Mental Disorder, Nervous System Disorders
- Trial name
- NCT02050854
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.
- Trial name
- NCT01870999
- Testing
- aripiprazole IM depot, aripiprazole tablets
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.