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.
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.
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.
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.
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.
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.
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.
Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2.
- Trial name
- NCT04362007
- Testing
- ASTX660
- Where
- Japan
- Volunteers
- 8 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia
- Trial name
- NCT05687071
- Testing
- 180mg of ETC-1002(bempedoic acid)
- Where
- Japan
- Volunteers
- 130 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Schizophrenia
Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.
- Trial name
- NCT06036108
- Testing
- OPC-34712FUM/ Brexpiprazole fumarate
- Where
- Japan
- Volunteers
- 59 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Schizophrenia
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
- Trial name
- NCT07225712
- Testing
- SEP-363856
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Attention-Deficit Hyperactivity Disorder(ADHD)
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
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 pediatric ADHD patients.
- Trial name
- NCT07086313
- Testing
- EB-1020 (Centanafadine) low dose, EB-1020 (Centanafadine) high dose
- Where
- Japan
- Volunteers
- 315 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Attention-Deficit Hyperactivity Disorder(ADHD)
A Long-term Trial of EB-1020 in Pediatric 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 pediatric ADHD patients.
- Trial name
- NCT07087327
- Testing
- EB-1020 (Centanafadine) low dose, EB-1020 (Centanafadine) high dose
- Where
- Japan
- Volunteers
- 180 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Polycystic Kidney, Autosomal Dominant
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.
- Trial name
- NCT02847624
- Testing
- tolvaptan
- Where
- Japan
- Volunteers
- 1,802 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Cardiac Edema (CHF)
A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics…
- Trial name
- NCT05615363
- Testing
- OPC 131461 10mg group, OPC 131461 5mg group, OPC 131461 2mg group
- Where
- Japan
- Volunteers
- 157 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Atopic Dermatitis (AD)
A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
- Trial name
- NCT07184645
- Testing
- OPA-15406, Vehicle
- Where
- Japan
- Volunteers
- 198 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.