Clinical trials: completed, sponsored by 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.
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 Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis
- Trial name
- NCT05372653
- Testing
- OPA-15406
- Where
- Japan
- Volunteers
- 41 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein…
- Trial name
- NCT05683340
- Testing
- 180mg of ETC-1002(bempedoic acid)
- Where
- Japan
- Volunteers
- 96 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Agitation Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the…
- Trial name
- NCT03620981
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 410 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Agitation Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy…
- Trial name
- NCT03724942
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 164 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Major Depressive Disorder
A Phase 2 Trial of OPC-64005 for Major Depressive Disorder
The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary…
- Trial name
- NCT04244253
- Testing
- OPC-64005 20 mg , Once-daily, OPC-64005 10 mg , Once-daily
- Where
- Japan
- Volunteers
- 273 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
- Trial name
- NCT03255226
- Testing
- Tolvaptan
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Major Depressive Disorder
A Study of Brexpiprazole in Patients With Major Depressive Disorder
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy…
- Trial name
- NCT03697603
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 740 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Autistic Disorder
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
- Trial name
- NCT01617460
- Testing
- Aripiprazole
- Where
- 5 sites in Japan
- Volunteers
- 86 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Schizophrenia
A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses
To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.
- Trial name
- NCT04118127
- Testing
- 2mg conventional tablet, once-weekly tablets
- Where
- Japan
- Volunteers
- 73 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hypercholesterolemia
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or…
- Trial name
- NCT04784442
- Testing
- 180mg of ETC-1002(bempedoic acid), 120mg of ETC-1002(bempedoic acid), 60mg of ETC-1002(bempedoic acid)
- Where
- Japan
- Volunteers
- 188 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Major Depressive Disorder
A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder
This trial is a 52-week study to assess the safety of long-term use of brexpiprazole as adjunctive therapy in combination with an antidepressant.
- Trial name
- NCT03737474
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 248 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Migraine
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at 675 mg every 3 months) for the preventive…
- Trial name
- NCT03303105
- Testing
- TEV-48125
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Atopic Dermatitis
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
- Trial name
- NCT03961529
- Testing
- 0.3% OPA-15406 ointment, 1% OPA-15406 ointment
- Where
- Japan
- Volunteers
- 366 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Migraine
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home.
- Trial name
- NCT04355117
- Testing
- Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
- Where
- Japan
- Volunteers
- 71 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Head and Neck Cancer
A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer
To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.
- Trial name
- NCT02085460
- Testing
- 2% Rebamipide liquid, 4% Rebamipide liquid
- Where
- 5 sites in Japan
- Volunteers
- 94 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy
Pharmacodynamic Study of Cilostazol in Healthy Volunteers
The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo…
- Trial name
- CiloMecT (NCT02554721)
- Testing
- Cilostazol, Acetylsalicylic acid, Clopidogrel
- Where
- Germany
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.