Clinical trials: sponsored by Otsuka Pharmaceutical Co., Ltd.
Attention Deficit Hyperactivity Disorder (ADHD)
A Long-term Trial of EB-1020 in Adult Patients With ADHD
The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan
- Trial name
- NCT06926829
- Testing
- EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg
- Where
- Japan
- Volunteers
- 180 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Attention Deficit Hyperactivity Disorder (ADHD)
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.
- Trial name
- NCT06931080
- Testing
- EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg
- Where
- Japan
- Volunteers
- 630 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Lupus Nephritis
LUPKYNIS Drug-use Results Survey
The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.
- Trial name
- NCT07053891
- Testing
- Voclosporin (LUPKYNIS)
- Where
- Japan
- Volunteers
- 400 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Alzheimer Disease
REXULTI General Use Results Survey in Patients With Hyperactivity, or Aggressive Behavior Associated With Alzheimer's Dementia
The purpose of this study is to evaluate safety of REXULTI in patients under daily clinical settings. In addition, information on efficacy will be collected.
- Trial name
- NCT06875986
- Testing
- Brexpiprazole (Rexulti)
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Post-Traumatic Stress Disorder, PTSD
Software as a Medical Device for the Treatment of Patients With PTSD
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
- Trial name
- NCT06589505
- Testing
- Software as a Medical Device
- Where
- 35 sites in Japan
- Volunteers
- 52 people
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Digital Patient-Reported Assessment in Older Adults With Acute Leukemia
This pilot study will evaluate the feasibility of implementing a structured digital patient-reported assessment pathway in adults aged 65 years or older with acute leukemia at Hospital Universitario Central de Asturias, Oviedo…
- Trial name
- NCT07597590
- Testing
- Digital Patient-Reported Assessment Pathway
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
Acute Schizophrenia
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
- Trial name
- NCT05325645
- Testing
- OPC-34712FUM/ Brexpiprazole fumarate
- Where
- Japan
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Multiple Myeloma (MM)
Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to evaluate the tolerability,safety and efficacy of OPC-415 in patients with relapsed and/or refractory Multiple Myeloma (MM).
- Trial name
- NCT04649073
- Testing
- OPC-415
- Where
- 8 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Schizophrenia
A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
Confirm the tolerability and safety of long-term administration of the brexpiprazole QW formulation in patients with schizophrenia
- Trial name
- NCT05326347
- Testing
- OPC-34712FUM/ Brexpiprazole fumarate
- Where
- Japan
- Volunteers
- 247 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Major Depressive Disorder (MDD)
REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness
Rejoyn is a Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD). This study aims to evaluate the feasibility, engagement, and clinical context of integrating Rejoyn into standard interventional…
- Trial name
- REWIRE (NCT07792252)
- Testing
- Rejoyn, Cognitive Behavioral Therapy (CBT) exercises
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Hyponatremias, Water Intoxication
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.
- Conditions
- Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
- Trial name
- NCT00072683
- Testing
- tolvaptan
- Where
- 23 sites in United States
- Volunteers
- 205 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
Study of Ascending Levels of Tolvaptan in Hyponatremia
The purpose of this study was to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal and to characterize and quantify the potential clinical benefits of this…
- Trial name
- SALT2 (NCT00201994)
- Testing
- Tolvaptan
- Where
- Germany
- Volunteers
- 243 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Multidrug-Resistant
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs.
- Trial name
- DRAMATIC (NCT03828201)
- Testing
- Delamanid, Levofloxacin, Bedaquiline
- Where
- 2 sites in Philippines, Vietnam
- Volunteers
- 271 people
- Sponsor
- Boston University
Migraine Disorders
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use
To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.
- Trial name
- NCT05342493
- Testing
- Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution
- Where
- Japan
- Volunteers
- 1,000 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Heart Failure
Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.
To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.
- Trial name
- NCT05712746
- Testing
- Samtasu for I.V. infusion
- Where
- Japan
- Volunteers
- 1,600 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Antidiuretic Hormone, Inappropriate Secretion
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan
- Trial name
- NCT04790175
- Testing
- Tolvaptan (SAMSCA)
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Pulmonary Tuberculosis
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid…
- Trial name
- NCT05971602
- Testing
- Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)
- Where
- 13 sites in Philippines, South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes).
- Trial name
- OVERTURE (NCT01430494)
- Where
- 266 sites in United States, Argentina and 18 more
- Volunteers
- 3,409 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Relapsed or Refractory Diffuse Large B-cell Lymphoma
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
- Trial name
- NCT04049825
- Testing
- OPB-111077
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Cerebral Infarction, Stenosis Artery
The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis
Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial.
- Trial name
- CHANGE (NCT06757764)
- Testing
- Aspirin, Clopidogrel, Cilostazol
- Where
- 24 sites in South Korea
- Volunteers
- 2,340 people
- Sponsor
- Asan Medical Center