OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

🇺🇸United States

Country: 🇺🇸United States

Ownership: Subsidiary

Employees: -

Market Cap: -

Website: http://www.otsuka-us.com

Clinical Trials

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

Phase 3

Completed

Conditions: Depression
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders

Interventions: Drug: OPC-34712
Drug: Venlafaxine XR
Drug: Sertraline
Drug: Fluoxetine
Drug: Paroxetine CR
Drug: Escitalopram
Drug: Duloxetine

First Posted Date: 2011-05-26

Last Posted Date: 2018-09-17

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 2944

Registration Number: NCT01360866

Locations: 🇺🇦
Research Site, Poltava, Ukraine

Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

Phase 3

Completed

Conditions: Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders

Interventions: Drug: OPC-34712 + ADT
Drug: Placebo + ADT

First Posted Date: 2011-05-25

Last Posted Date: 2016-01-01

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 1539

Registration Number: NCT01360632

Locations: 🇺🇦
Research Site, Poltava, Ukraine

Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)

Phase 3

Completed

Conditions: Mood Disorders
Depressive Disorder, Major
Mental Disorders
Depression
Depressive Disorder

Interventions: Drug: OPC-34712 + ADT
Drug: Placebo + ADT

First Posted Date: 2011-05-25

Last Posted Date: 2015-11-26

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 826

Registration Number: NCT01360645

Locations: 🇸🇰
Research Site, Michalovce, Slovakia

Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Phase 2

Completed

Conditions: Autosomal Dominant Polycystic Kidney Disease

Interventions: Drug: Tolvaptan

First Posted Date: 2011-04-18

Last Posted Date: 2019-03-05

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 29

Registration Number: NCT01336972

Locations: 🇳🇱
University Medical Center Groningen, Groningen, Netherlands

A Study Evaluating the of OPC-34712 in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects

Phase 1

Completed

Conditions: Schizophrenia

Interventions: Drug: OPC-34712

First Posted Date: 2011-02-18

Last Posted Date: 2015-10-20

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 45

Registration Number: NCT01299454

Locations: 🇺🇸
Study Site, San Antonio, Texas, United States

Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects

Phase 1

Completed

Conditions: Schizophrenia
Psychiatric Disorders

Interventions: Drug: OPC-34712

First Posted Date: 2011-02-03

Last Posted Date: 2015-10-29

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 19

Registration Number: NCT01289080

Locations: 🇺🇸
Otsuka Investigational Site, Minneapolis, Minnesota, United States

Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)

Completed

Conditions: Depressive Disorder, Major

First Posted Date: 2011-01-26

Last Posted Date: 2013-11-08

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 23514

Registration Number: NCT01284218

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia

Phase 3

Terminated

Conditions: Hyponatremia
Inappropriate ADH Syndrome
Dilutional Hyponatremia

Interventions: Other: Fluid Restriction
Drug: tolvaptan

First Posted Date: 2010-10-25

Last Posted Date: 2014-10-30

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 124

Registration Number: NCT01227512

Locations: 🇺🇸
Otuska Investigational Site, Orange, California, United States
🇺🇸
Otsuka Investigational Site, Madison, Wisconsin, United States

Tolvaptan Extension Study in Participants With ADPKD

Phase 3

Completed

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions: Drug: Tolvaptan

First Posted Date: 2010-10-05

Last Posted Date: 2021-10-25

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 1083

Registration Number: NCT01214421

Locations: 🇬🇧
Otsuka Investigational Site, Swansea, United Kingdom

Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD

Phase 2

Completed

Conditions: Autosomal Dominant Polycystic Kidney Disease

Interventions: Drug: Tolvaptan MR
Drug: Tolvaptan IR

First Posted Date: 2010-09-28

Last Posted Date: 2018-06-14

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 25

Registration Number: NCT01210560

Locations: 🇺🇸
Mayo Medical Center, Rochester, Minnesota, United States
🇺🇸
Davita Clinical Research, Minneapolis, Minnesota, United States
🇺🇸
Tufts-New England Medical Center, Boston, Massachusetts, United States

and more 3 locations

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