Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Lead sponsor (exact) Otsuka Pharmaceutical Development & Commercialization, Inc.
- Has posted results yes
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.
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.
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
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.
Bipolar Disorder Mania
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
- Trial name
- NCT00665366
- Testing
- Aripiprazole, Lithium, Valproate
- Where
- 73 sites in Austria, Czechia and 11 more
- Volunteers
- 493 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Schizoaffective Disorder
Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome
The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder, Metabolic Syndrome
- Trial name
- NCT00857818
- Testing
- Aripiprazole, Oanzapine, risperidone, or quetiapine
- Where
- 14 sites in Canada
- Volunteers
- 64 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
A Study of Aripiprazole in Patients With Major Depressive Disorder
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy…
- Trial name
- NCT00105196
- Testing
- Aripiprazole+ ADT
- Where
- 34 sites in United States
- Volunteers
- 349 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Dementia, Alzheimer Type
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.
- Trial name
- NCT01438060
- Testing
- Aripiprazole (BMS-337039)
- Volunteers
- 232 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Oral Aripiprazole Open-Label Rollover Study
The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
- Trial name
- NCT01001702
- Testing
- Aripiprazole
- Where
- 15 sites in Argentina, Croatia and 4 more
- Volunteers
- 85 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia.
- Trial name
- ASPIRE (NCT00705783)
- Testing
- Aripiprazole depot
- Where
- 110 sites in United States, Argentina and 10 more
- Volunteers
- 843 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Aripiprazole in Adolescents With Schizophrenia
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
- Trial name
- APEX 239 (NCT00102063)
- Testing
- Aripiprazole tablet, 10 mg, Aripiprazole tablet, 30 mg
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 302 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
Aripiprazole in Children and Adolescents With Bipolar I Disorder
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
- Trial name
- NCT00110461
- Testing
- Aripiprazole
- Where
- 53 sites in United States
- Volunteers
- 296 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
- Trial name
- INSIGHT (NCT00550459)
- Testing
- Tolvaptan
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.