Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Lead sponsor (exact) Otsuka Pharmaceutical Development & Commercialization, Inc.
- Has posted results yes
Schizophrenia
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.
- Trial name
- NCT03896945
- Testing
- AVP-786
- Where
- 72 sites in United States, Bulgaria and 2 more
- Volunteers
- 136 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autistic Disorder, Behavioral Symptoms
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241]…
- Trial name
- NCT00365859
- Testing
- Aripiprazole
- Where
- 55 sites in United States
- Volunteers
- 330 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04092686
- Testing
- SEP-363856 75mg, SEP-363856 100mg
- Where
- 53 sites in United States, Bulgaria and 5 more
- Volunteers
- 464 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832.
- Trial name
- NCT07542847
- Testing
- OPC-167832, Itraconazole, Carbamazepine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into…
- Trial name
- ASPIRE (NCT00706654)
- Testing
- Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally, Aripiprazole depot 25 or 50 mg
- Where
- 98 sites in United States, Austria and 13 more
- Volunteers
- 937 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04072354
- Testing
- SEP-363856 50mg, SEP-363856 75mg
- Where
- 53 sites in United States, Bulgaria and 4 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Adult ADHD
Study of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 Sustained Release (SR) in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder
This was a Phase 2 exploratory study to evaluate the efficacy and safety of EB-1020 SR (centanafadine sustained release [CTN SR]) in treating participants who met Diagnostic and Statistical Manual of Mental Disorders, Fourth…
- Trial name
- NCT01939353
- Testing
- CTN SR
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Behavioral Symptoms, Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00337571
- Testing
- Aripiprazole
- Where
- 31 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Trial name
- NCT00277212
- Testing
- Lamotrigine + Aripiprazole
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 1,169 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00332241
- Testing
- Aripiprazole
- Where
- 9 sites in United States
- Volunteers
- 98 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Disinhibition Syndrome
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
- Trial name
- NCT02534038
- Testing
- AVP-786
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multiple Myeloma
IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.
- Trial name
- NCT01009840
- Testing
- IV busulfan, bortezomib, Autologous Hematopoietic Stem Cell Transplant (HSCT)
- Where
- 13 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.
- Trial name
- NCT02477670
- Testing
- AVP-786
- Where
- 17 sites in United States
- Volunteers
- 145 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL.
- Conditions
- Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy, IgA Nephropathy
- Trial name
- NCT03719443
- Testing
- VIS649
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants
This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.
- Trial name
- NCT06212804
- Testing
- VIS954
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Immunoglobulin A Nephropathy, Glomerular Disease
Safety and Efficacy Study of VIS649 for IgA Nephropathy
The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)
- Conditions
- Immunoglobulin A Nephropathy, Glomerular Disease, IgAN
- Trial name
- NCT04287985
- Testing
- Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649
- Where
- 93 sites in United States, Australia and 13 more
- Volunteers
- 155 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
- Trial name
- NCT03238326
- Testing
- Brexpiprazole
- Where
- 57 sites in United States, France and 8 more
- Volunteers
- 295 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia. This study is accepting male and female participants between 18 years old -65 years old who have been…
- Trial name
- NCT04115319
- Testing
- SEP363856, quetiapine XR
- Where
- 42 sites in United States, Romania and 2 more
- Volunteers
- 305 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.