Clinical trials: sponsored by Otsuka Pharmaceutical Co., Ltd.
Idiopathic Restless Legs Syndrome
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple…
- Trial name
- NCT00666965
- Testing
- SPM 962
- Where
- 8 sites in Japan
- Volunteers
- 230 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Idiopathic Restless Legs Syndrome
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a…
- Trial name
- RLS (NCT01562743)
- Testing
- SPM 962
- Volunteers
- 185 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease
A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM…
- Trial name
- NCT01628848
- Testing
- SPM 962
- Where
- 7 sites in Japan
- Volunteers
- 174 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease
A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients
The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5…
- Trial name
- NCT01631812
- Testing
- SPM 962
- Where
- 7 sites in Japan
- Volunteers
- 130 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease
A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients
The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient…
- Trial name
- NCT01634243
- Testing
- SPM 962
- Where
- 5 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease
A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients
Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses.
- Trial name
- NCT01628965
- Testing
- SPM 962
- Where
- 7 sites in Japan
- Volunteers
- 143 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Early Parkinson's Disease
A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5…
- Trial name
- NCT00537485
- Testing
- SPM 962
- Where
- 6 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease
A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in…
- Trial name
- NCT01631825
- Testing
- SPM 962
- Where
- 8 sites in Japan
- Volunteers
- 321 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Cirrhosis
A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in…
- Trial name
- NCT00479336
- Testing
- OPC-41061 7.5mg, OPC-41061 15mg, OPC-41601 30mg
- Where
- 7 sites in Japan
- Volunteers
- 104 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar I Disorder
A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed…
- Trial name
- NCT00606229
- Testing
- Aripiprazole
- Where
- 5 sites in Japan
- Volunteers
- 41 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Cirrhosis
A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema
OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at…
- Trial name
- NCT01050530
- Testing
- OPC-41061
- Where
- 8 sites in Japan
- Volunteers
- 162 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Cirrhosis
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics…
- Trial name
- NCT01114828
- Testing
- OPC-41061
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Dry Eye Syndromes
Dose-response Study of OPC-12759 Ophthalmic Suspension
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.
- Trial name
- NCT00234078
- Testing
- 0.5% OPC-12759, 1% OPC-12759, 2% OPC-12759
- Where
- Japan
- Volunteers
- 290 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Dry Eye Syndromes
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients
- Trial name
- NCT00818324
- Testing
- OPC-12759 Ophthalmic suspension
- Where
- 5 sites in Japan
- Volunteers
- 154 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar I Disorder
A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those…
- Trial name
- NCT00606320
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 59 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar I Disorder
A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel…
- Trial name
- NCT00606177
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 99 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar I Disorder
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
- Trial name
- NCT00606281
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 258 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Schizophrenia
Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-
The objective of this study is to examine the effects of aripiprazole on glucose metabolism in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.
- Trial name
- NCT00392197
- Testing
- Aripiprazole
- Where
- 5 sites in Japan
- Volunteers
- 111 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Major Depressive Disorder
Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in…
- Trial name
- NCT00876343
- Testing
- Aripiprazole (Fixed dose), Aripiprazole (Titrated dose)
- Where
- 8 sites in Japan
- Volunteers
- 586 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Major Depressive Disorder
Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
To examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (SSRI) or a selective-norepinephrine reuptake inhibitor…
- Trial name
- NCT00882362
- Testing
- OPC-14597 (Aripiprazole)
- Where
- 8 sites in Japan
- Volunteers
- 155 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.