Clinical trials: sponsored by Otsuka Pharmaceutical Co., Ltd.
Atopic Dermatitis (AD)
A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis
To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).
- Trial name
- NCT07173478
- Testing
- OPA-15406, Vehicle
- Where
- Japan
- Volunteers
- 156 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Safety
Samsca PMS in ADPKD Patients
This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and…
- Trial name
- NCT03406286
- Testing
- Tolvaptan
- Where
- South Korea
- Volunteers
- 2,067 people
- Sponsor
- Korea 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.
Bipolar Disorder I
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of…
- Trial name
- NCT04812379
- Testing
- Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)
- Where
- Japan
- Volunteers
- 535 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Alcohol Dependence
Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine…
- Trial name
- NCT04107051
- Testing
- Nalmefene Hydrochloride Hydrate
- Where
- Japan
- Volunteers
- 533 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Lower-risk Myelodysplastic
Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes
To investigate the tolerability and safety of ASTX727 in Japanese subjects with lower-risk MDS.
- Trial name
- NCT03906695
- Testing
- ASTX727
- Where
- Japan
- Volunteers
- 30 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.
Tuberculosis, Multidrug-Resistant
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
- Trial name
- NCT06674291
- Testing
- No intervention (observational study)
- Volunteers
- 222 people
- Sponsor
- Korea 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.
Depression, Bipolar
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or…
- Trial name
- APOLLO (NCT03423680)
- Testing
- Abilify 2, 5, 10, 15mg (Tablet)
- Where
- South Korea
- Volunteers
- 390 people
- Sponsor
- Korea 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.
Acute Gastritis, Chronic Gastritis
Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.
This PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'.
- Trial name
- MCTSRPMS (NCT05048069)
- Testing
- Mucosta®SR Tablets 150mg(Rebamipide)
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Korea 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.