Tolvaptan

Generic Name
Tolvaptan
Brand Names
Jinarc, Jynarque 45/15 Carton, Samsca, Tolvaptan Accord, Xeljanz
Drug Type
Small Molecule
Chemical Formula
C26H25ClN2O3
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
-

An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2013-12-24
Last Posted Date
2020-04-17
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
3
Registration Number
NCT02020278

Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2013-12-17
Last Posted Date
2018-09-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
9
Registration Number
NCT02012959

A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

First Posted Date
2013-12-12
Last Posted Date
2016-05-16
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
30
Registration Number
NCT02009878
Locations
🇪🇸

Hospital Universitario Clinico San Carlos, Madrid, Spain

🇩🇪

Medizinische Klinik im Klinikum Hannover, Hannover, Niedersachsen, Germany

🇨🇿

Vseobecna fakultni nemocnice V Praze, Praha, Czech Republic

and more 11 locations

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

First Posted Date
2013-11-05
Last Posted Date
2020-05-21
Lead Sponsor
Pfizer
Target Recruit Count
686
Registration Number
NCT01976364
Locations
🇺🇸

Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States

🇧🇪

ZNA Jan Palfijn, Merksem, Belgium

🇧🇷

Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS, Porto Alegre, RS, Brazil

and more 148 locations

Effects of Tolvaptan in Healthy Adults

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-10-31
Last Posted Date
2016-09-28
Lead Sponsor
Northwestern University
Target Recruit Count
17
Registration Number
NCT01973140
Locations
🇺🇸

Clinical Research Unit Northwestern Memorial Hospital, Chicago, Illinois, United States

Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia

First Posted Date
2013-07-02
Last Posted Date
2017-12-11
Lead Sponsor
NYU Langone Health
Target Recruit Count
2
Registration Number
NCT01890694
Locations
🇺🇸

NYU Langone Medical Center, New York, New York, United States

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-06-20
Last Posted Date
2017-09-15
Lead Sponsor
Pfizer
Target Recruit Count
395
Registration Number
NCT01882439
Locations
🇺🇸

St. Luke's Intermountain Research Center, Boise, Idaho, United States

🇺🇸

Clinical Pharmacology Study Group, Worcester, Massachusetts, United States

🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

and more 122 locations

Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure

First Posted Date
2013-05-29
Last Posted Date
2016-01-28
Lead Sponsor
The Christ Hospital
Target Recruit Count
45
Registration Number
NCT01863511
Locations
🇺🇸

The Christ Hospital, Cincinnati, Ohio, United States

Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia

First Posted Date
2013-05-10
Last Posted Date
2015-07-28
Lead Sponsor
Beijing Friendship Hospital
Target Recruit Count
98
Registration Number
NCT01850940
Locations
🇨🇳

Peking University First Hospital, Beijing, Beijing, China

🇨🇳

Guangdong General Hospital, Guangdong, Guangdong, China

🇨🇳

Beijing Ditan Hospital, Beijing, Beijing, China

and more 16 locations

A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

First Posted Date
2012-12-05
Last Posted Date
2017-11-20
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
67
Registration Number
NCT01741493
Locations
🇺🇸

Site Reference ID/Investigator# 95815, Duncansville, Pennsylvania, United States

🇺🇸

Site Reference ID/Investigator# 95817, Miami, Florida, United States

🇺🇸

Site Reference ID/Investigator# 95816, Cincinnati, Ohio, United States

and more 2 locations
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