Tolvaptan

Generic Name: Tolvaptan

Brand Names: Jinarc, Jynarque 45/15 Carton, Samsca, Tolvaptan Accord, Xeljanz

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₅ClN_₂O_₃

CAS Number: 150683-30-0

Unique Ingredient Identifier: 1E2497LPNY

Background: Tolvaptan is used to treat low blood sodium levels (hyponatremia) associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). FDA approved on May 19, 2009.

Indication: Treatment of symptomatic and resistant to fluid restriction euvolemic or hypervolemic hyponatremia associated with congestive heart failure, SIADH, and cirrhosis.

Associated Conditions: Autosomal Dominant Polycystic Kidney Disease （ADPKD), Symptomatic euvolemic Hyponatremia, Symptomatic hypervolemic Hyponatremia

Associated Therapies: -

Clinical Trials

Pilot Study of Using Copeptin to Predict Response to Tolvaptan

Phase 4

Completed

Conditions: Heart Diseases
Heart Failure
Cardiovascular Diseases

Interventions: Drug: tolvaptan

First Posted Date: 2011-05-02

Last Posted Date: 2017-05-17

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 21

Registration Number: NCT01346072

Locations: 🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

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

Tolvaptan for Ascites in Cirrhotic Patients

Phase 4

Completed

Conditions: Ascites
Cirrhosis

Interventions: Drug: Tolvaptan

First Posted Date: 2011-02-09

Last Posted Date: 2015-07-27

Lead Sponsor: University of Florida

Target Recruit Count: 10

Registration Number: NCT01292304

Locations: 🇺🇸
University of Florida Hepatology, Gainesville, Florida, United States

A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

Phase 3

Completed

Conditions: Autosomal Dominant Polycystic Kidney Disease （ADPKD)

Interventions: Drug: tolvaptan

First Posted Date: 2011-01-21

Last Posted Date: 2019-01-17

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 135

Registration Number: NCT01280721

Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tolvaptan

First Posted Date: 2010-12-16

Last Posted Date: 2012-12-07

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 29

Registration Number: NCT01261481

Locations: 🇺🇸
University of North Carolina Healthcare, Chapel Hill, North Carolina, United States

Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice

Conditions: Non-Hyponatremia
SIADH
Non-SIADH Hyponatremia

Interventions: Drug: Tolvaptan

First Posted Date: 2010-10-26

Last Posted Date: 2013-05-01

Lead Sponsor: Otsuka Frankfurt Research Institute GmbH

Target Recruit Count: 200

Registration Number: NCT01228682

Locations: 🇮🇹
Otsuka Study location 39-001, Cuneo, Italy
🇮🇹
Otsuka Study location 39.007, Florence, Italy
🇮🇹
Otsuka Study location 39.005, Siena, Italy

and more 44 locations

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

A Study Of Tasocitinib In Dry Eye Subjects

Phase 2

Withdrawn

Conditions: Keratoconjunctivitis Sicca

Interventions: Drug: Tasocitinib
Drug: vehicle for Tasocitinib

First Posted Date: 2010-10-22

Last Posted Date: 2018-11-29

Lead Sponsor: Pfizer

Registration Number: NCT01226680

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

Tolvaptan in Hyponatremic Cancer Patients

Phase 4

Completed

Conditions: Advanced Cancers

Interventions: Drug: Placebo
Drug: Tolvaptan

First Posted Date: 2010-09-10

Last Posted Date: 2020-09-23

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 52

Registration Number: NCT01199198

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

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