Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Lead sponsor (exact) Otsuka Pharmaceutical Development & Commercialization, Inc.
- Age group Children (under 18)
- Has posted results yes
Irritability Associated With Autistic Disorder
Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder
The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when…
- Trial name
- NCT01227668
- Testing
- Aripiprazole
- Where
- 38 sites in United States
- Volunteers
- 215 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autistic Disorder, Behavioral Symptoms
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241]…
- Trial name
- NCT00365859
- Testing
- Aripiprazole
- Where
- 55 sites in United States
- Volunteers
- 330 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04072354
- Testing
- SEP-363856 50mg, SEP-363856 75mg
- Where
- 53 sites in United States, Bulgaria and 4 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00332241
- Testing
- Aripiprazole
- Where
- 9 sites in United States
- Volunteers
- 98 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Behavioral Symptoms, Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00337571
- Testing
- Aripiprazole
- Where
- 31 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
- Trial name
- NCT03238326
- Testing
- Brexpiprazole
- Where
- 57 sites in United States, France and 8 more
- Volunteers
- 295 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Irritability Associated With Autism Spectrum Disorder (ASD)
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
- Trial name
- NCT04174365
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Irritability Associated With Autism Spectrum Disorder
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
- Trial name
- NCT04258839
- Testing
- Brexpiprazole
- Where
- 28 sites in United States
- Volunteers
- 95 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
- Trial name
- NCT03198078
- Testing
- Brexpiprazole (OPC-34712), Aripiprazole
- Where
- United States
- Volunteers
- 316 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Hyperactivity Disorder
Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal…
- Trial name
- NCT04081363
- Testing
- Centanafadine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- NCT02964273
- Testing
- Tolvaptan
- Where
- 20 sites in Belgium, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Atopic Dermatitis
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
- Trial name
- NCT02068352
- Testing
- OPA-15406, Vehicle ointment
- Where
- 30 sites in United States, Australia and 1 more
- Volunteers
- 121 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01416441
- Testing
- Aripiprazole
- Where
- 80 sites in United States, Bulgaria and 8 more
- Volunteers
- 170 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01418339
- Testing
- Aripiprazole
- Where
- 39 sites in United States, Canada and 4 more
- Volunteers
- 135 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)
The goal of the current trial is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01418352
- Testing
- Aripiprazole
- Where
- 35 sites in United States, Bulgaria and 3 more
- Volunteers
- 83 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder (TD)
Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder
To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).
- Trial name
- NCT03661983
- Testing
- Aripiprazole
- Where
- 42 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and…
- Trial name
- NCT02020278
- Testing
- Tolvaptan
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 3 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02012959
- Testing
- Tolvaptan
- Where
- 7 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.