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
-

Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2014-12-09
Last Posted Date
2017-11-06
Lead Sponsor
Stanford University
Target Recruit Count
40
Registration Number
NCT02312882
Locations
🇺🇸

Stanford University, Stanford, California, United States

Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-11-24
Last Posted Date
2019-05-07
Lead Sponsor
Columbia University
Target Recruit Count
12
Registration Number
NCT02299297
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-11-02
Last Posted Date
2018-10-12
Lead Sponsor
Pfizer
Target Recruit Count
209
Registration Number
NCT02281552
Locations
🇯🇵

National Hospital Organization Toyohashi Medical Center, Toyohashi, Aichi, Japan

🇯🇵

Yamada Rheumatology Clinic, Matsuyama, Ehime, Japan

🇯🇵

Inoue Hospital, Tohrimachi, Takasaki, Gunma, Japan

and more 33 locations

Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-09-29
Last Posted Date
2019-11-27
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
1803
Registration Number
NCT02251275

Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients

Terminated
Conditions
Interventions
First Posted Date
2014-08-13
Last Posted Date
2016-09-08
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
1
Registration Number
NCT02215148
Locations
🇺🇸

Barnes-Jewish Hospital, St. Louis, Missouri, United States

🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

🇺🇸

University of North Carolina Hospitals, Chapel Hill, North Carolina, United States

Aquaresis Utility for Hyponatremic Acute Heart Failure Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-07-08
Last Posted Date
2019-05-28
Lead Sponsor
University of Southern California
Target Recruit Count
33
Registration Number
NCT02183792
Locations
🇺🇸

Keck Medical Center of USC, Los Angeles, California, United States

🇺🇸

LAC+USC Medical Center, Los Angeles, California, United States

Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites

First Posted Date
2014-06-24
Last Posted Date
2017-09-19
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
50
Registration Number
NCT02173288
Locations
🇮🇳

Dept. of Hepatology, PGIMER, Chandigarh, Chandigarh, India

A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-05-28
Last Posted Date
2018-04-11
Lead Sponsor
Pfizer
Target Recruit Count
112
Registration Number
NCT02147587
Locations
🇺🇸

Rheumatology Consultants, PLLC, Knoxville, Tennessee, United States

🇺🇸

Baylor Research Institute Arthritis Care and Research Center, Dallas, Texas, United States

🇺🇸

Center for Arthritis and Rheumatic Diseases, Miami, Florida, United States

and more 33 locations

Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study

First Posted Date
2014-03-26
Last Posted Date
2016-03-30
Lead Sponsor
Mayo Clinic
Target Recruit Count
20
Registration Number
NCT02096965
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

First Posted Date
2014-03-20
Last Posted Date
2021-08-17
Lead Sponsor
Pfizer
Target Recruit Count
4372
Registration Number
NCT02092467
Locations
🇺🇸

Arthritis and Rheumatology of GA, P.C., Atlanta, Georgia, United States

🇺🇸

Baylor Scott and White Research Institute / Arthritis Care and Research Center, Dallas, Texas, United States

🇺🇸

UPMC Arthritis and Autoimmunity Clinic, Pittsburgh, Pennsylvania, United States

and more 336 locations
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