Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Pancreatic Cancer
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care…
- Trial name
- LAPC (NCT01395017)
- Testing
- dasatinib
- Where
- 74 sites in United States, Australia and 13 more
- Volunteers
- 202 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Solid Tumors
A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer
The primary objective of this study is to determine the safe and tolerable dose level of OPB-111077 for patients with advanced cancer.
- Trial name
- NCT01711034
- Testing
- OPB-111077
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
MDD
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment
To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin…
- Trial name
- NCT02013609
- Testing
- Brexpiprazole
- Where
- 24 sites in United States
- Volunteers
- 48 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability.
- Trial name
- NCT02013622
- Testing
- Brexpiprazole
- Where
- 22 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder, Anxiety
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms
The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate…
- Trial name
- NCT02013531
- Testing
- Brexpiprazole
- Where
- 21 sites in United States
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week…
- Trial name
- NCT00797966
- Testing
- OPC-34712, ADT
- Where
- 50 sites in United States
- Volunteers
- 850 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.
- Trial name
- ATTAIN 267 (NCT01122927)
- Testing
- Aripiprazole
- Where
- 101 sites in United States, Bulgaria and 11 more
- Volunteers
- 524 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia
The purpose of this study is to determine how low and high does of brexpiprazole binds to certain receptors in the brain. This will be determined by PET scans taken pre-dose and post-dose.
- Trial name
- NCT01854944
- Testing
- Brexpiprazole 1mg to 4mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder
The purpose of this study is to assess the safety and tolerability of ascending multiple oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.
- Trial name
- NCT01670279
- Testing
- Brexpiprazole
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and…
- Trial name
- NCT02449044
- Testing
- Tolvaptan
- Volunteers
- 111 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Depressive Disorder, Depression
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who…
- Conditions
- Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders
- Trial name
- Polaris (NCT01360632)
- Testing
- OPC-34712 + ADT
- Where
- 71 sites in United States, Canada and 5 more
- Volunteers
- 1,539 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia
- Trial name
- NCT02054702
- Testing
- Brexpiprazole, Aripiprazole
- Volunteers
- 97 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder (MDD)
Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects' subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who have responded inadequately to preceding…
- Trial name
- NCT02012218
- Testing
- ADT, Brexpiprazole
- Where
- 24 sites in United States
- Volunteers
- 61 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Depressive Disorder, Depression
Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who…
- Conditions
- Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders
- Trial name
- Pyxis (NCT01360645)
- Testing
- OPC-34712 + ADT
- Where
- 57 sites in United States, Canada and 3 more
- Volunteers
- 826 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Schizophrenia
Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia
The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.
- Trial name
- BEACON (NCT01393613)
- Testing
- OPC-34712
- Where
- 60 sites in United States, Colombia and 6 more
- Volunteers
- 674 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
- Trial name
- NCT01447576
- Testing
- ADT, OPC-34712
- Where
- 32 sites in United States
- Volunteers
- 1,036 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved…
- Trial name
- STEP-D222 (NCT01052077)
- Testing
- OPC-34712, ADT
- Where
- 43 sites in United States
- Volunteers
- 773 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Psychiatric Disorders
Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects
This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects.
- Trial name
- NCT01289080
- Testing
- OPC-34712
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Schizoaffective Disorder
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects.
- Trial name
- NCT01423916
- Testing
- OPC-34712 (4mg), Moxifloxacin, OPC-34712 (12mg)
- Where
- 8 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Multicenter, Open-label, Safety and Tolerability Study
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis.
- Trial name
- STEP 210 (NCT01649557)
- Testing
- OPC-34712
- Where
- 68 sites in United States, Bulgaria and 10 more
- Volunteers
- 244 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.