Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Mental Disorder
Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
- Conditions
- Schizophrenia, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02219009
- Testing
- MIND1 System
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
- Trial name
- NCT02160145
- Testing
- Tolvaptan (OPC-41061)
- Where
- 230 sites in United States, Argentina and 20 more
- Volunteers
- 1,370 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1.
- Trial name
- NCT01210560
- Testing
- Tolvaptan MR, Tolvaptan IR
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
- Trial name
- NCT03150771
- Testing
- Aripiprazole
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
ADHD, Autism
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
- Conditions
- ADHD, Autism, Bipolar I Disorder, Conduct Disorder
- Trial name
- NCT03292848
- Testing
- Brexpiprazole
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Depressive Disorder, Depression
A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.
- Conditions
- Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders
- Trial name
- NCT01727726
- Testing
- Brexpiprazole, Seroquel XR
- Where
- 76 sites in United States, Canada and 5 more
- Volunteers
- 2,182 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Major Depressive Disorder
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT02722967
- Testing
- Aripiprazole + IEM (Ingestible Event Marker)
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With Alzheimer's Disease, Alzheimer's Type
Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo
To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.
- Conditions
- Agitation Associated With Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02192554
- Where
- 84 sites in United States, Bulgaria and 10 more
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia
To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered subcutaneously or intramuscularly in adults with schizophrenia.
- Trial name
- NCT02968121
- Testing
- Brexpiprazole, OPDC-34712
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent subjects with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02442674
- Testing
- Tolvaptan
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Polycystic Kidney, Autosomal Dominant
Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease…
- Trial name
- TEMPO 2:4 (NCT00413777)
- Testing
- Tolvaptan
- Where
- 11 sites in United States
- Volunteers
- 46 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Polycystic Kidney Disease, Autosomal Dominant
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
- Trial name
- TEMPO3:4 (NCT00428948)
- Testing
- Tolvaptan
- Where
- 133 sites in United States, Argentina and 13 more
- Volunteers
- 1,445 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.
- Trial name
- ZENITH (NCT01397786)
- Testing
- OPC-34712
- Where
- 148 sites in United States, Canada and 17 more
- Volunteers
- 1,044 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Obstructive Pulmonary Disease
Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.
- Trial name
- EMPHASIS (NCT00874497)
- Testing
- tetomilast
- Where
- 15 sites in United States
- Volunteers
- 84 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation
The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- CADENCE 215 (NCT01483183)
- Testing
- OPC-108459
- Where
- 25 sites in United States, Germany and 4 more
- Volunteers
- 40 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Schizophrenia
Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.
- Trial name
- EQUATOR (NCT01668797)
- Testing
- Brexpiprazole
- Where
- 49 sites in United States, Colombia and 6 more
- Volunteers
- 524 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder and Irritability
Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability
The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive treatment in subjects with Major Depressive Disorder with irritability
- Trial name
- NCT02212613
- Testing
- Brexpiprazole
- Where
- United States
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
This is a study to evaluate how the body handles and metabolizes (PK) the various doses of the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the content of "salt" in blood and urine
- Trial name
- NCT02009878
- Testing
- tolvaptan
- Where
- 14 sites in Czechia, Denmark and 5 more
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.