Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Oral Aripiprazole Open-Label Rollover Study
The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
- Trial name
- NCT01001702
- Testing
- Aripiprazole
- Where
- 15 sites in Argentina, Croatia and 4 more
- Volunteers
- 85 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia.
- Trial name
- ASPIRE (NCT00705783)
- Testing
- Aripiprazole depot
- Where
- 110 sites in United States, Argentina and 10 more
- Volunteers
- 843 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Aripiprazole in Adolescents With Schizophrenia
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
- Trial name
- APEX 239 (NCT00102063)
- Testing
- Aripiprazole tablet, 10 mg, Aripiprazole tablet, 30 mg
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 302 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
Aripiprazole in Children and Adolescents With Bipolar I Disorder
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
- Trial name
- NCT00110461
- Testing
- Aripiprazole
- Where
- 53 sites in United States
- Volunteers
- 296 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Ulcerative Colitis
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis.
- Trial name
- NCT00064441
- Testing
- OPC-6535 Tablets (drug)
- Where
- 23 sites in United States
- Volunteers
- 375 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Ulcerative Colitis
FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis.
- Trial name
- NCT00064454
- Testing
- OPC-6535 Tablets (drug)
- Where
- 28 sites in United States
- Volunteers
- 375 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Congestive Heart Failure
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).
- Trial name
- NCT00071331
- Testing
- Tolvaptan
- Where
- 378 sites in United States, Argentina and 16 more
- Volunteers
- 3,600 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Heart Failure, Congestive
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure.
- Trial name
- NCT00132886
- Testing
- tolvaptan
- Where
- 31 sites in United States, Romania
- Volunteers
- 140 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
- Trial name
- INSIGHT (NCT00550459)
- Testing
- Tolvaptan
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.
- Trial name
- NCT00805454
- Testing
- OPC-34712
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Ulcerative Colitis
CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of…
- Trial name
- NCT00092508
- Testing
- OPC-6535, Asacol®
- Where
- 26 sites in United States
- Volunteers
- 1,725 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Congestive Heart Failure
Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
The purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (CHF)
- Trial name
- NCT00043758
- Testing
- Tolvaptan
- Where
- 40 sites in United States, Canada
- Volunteers
- 170 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Congestive Heart Failure
Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
Patients with congestive heart failure will be assessed for safety and clinical effects of Tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.
- Trial name
- NCT00043771
- Testing
- Tolvaptan
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.