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
- -
A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
- First Posted Date
- 2008-04-22
- Last Posted Date
- 2010-03-08
- Lead Sponsor
- Otsuka Beijing Research Institute
- Target Recruit Count
- 240
- Registration Number
- NCT00664014
- Locations
- 🇨🇳
Cardiology / Hepatology, Beijing Friendship Hospital, Beijing, China
🇨🇳Cardiology / Endocrinology, Peking Union Medical College Hospital, Beijing, China
🇨🇳Cardiology, Tianjin Medical University Second Hospital, Tianjin, China
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
- First Posted Date
- 2007-10-29
- Last Posted Date
- 2011-04-28
- Target Recruit Count
- 57
- Registration Number
- NCT00550459
- Locations
- 🇺🇸
Lillestol Research, LLC, Fargo, North Dakota, United States
🇺🇸Otis Barnum, DO, Natchitoches, Louisiana, United States
🇺🇸Carolina Research Associates, Columbia, South Carolina, United States
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Conditions
- Interventions
- First Posted Date
- 2007-01-30
- Last Posted Date
- 2017-07-02
- Target Recruit Count
- 1445
- Registration Number
- NCT00428948
- Locations
- 🇺🇸
Apex Research of Riverside, Riverside, California, United States
🇺🇸Emory University School of Medicine, Atlanta, Georgia, United States
🇺🇸University Hospitals of Cleveland/Case, Cleveland, Ohio, United States
Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- First Posted Date
- 2006-12-20
- Last Posted Date
- 2017-07-02
- Target Recruit Count
- 46
- Registration Number
- NCT00413777
- Locations
- 🇺🇸
Johns Hopkins School of Medicine, Baltimore, Maryland, United States
🇺🇸Jacksonville Center for Clinical Research, Jacksonville, Florida, United States
🇺🇸Emory University School of Medicine, Atlanta, Georgia, United States
"SALT-2 Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
- Conditions
- First Posted Date
- 2005-09-20
- Last Posted Date
- 2012-05-03
- Target Recruit Count
- 243
- Registration Number
- NCT00201994
- Locations
- 🇩🇪
Universitatskilinikum Carl, Gustav Carus, Dresden, Germany
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
- Conditions
- First Posted Date
- 2005-08-22
- Last Posted Date
- 2012-05-03
- Target Recruit Count
- 140
- Registration Number
- NCT00132886
- Locations
- 🇺🇸
Robert Rush University Medical Center, Chicago, Illinois, United States
🇺🇸Loyola University of Chicago, Maywood, Illinois, United States
🇺🇸Cleveland VA Medical Center, Cleveland, Ohio, United States
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
- Conditions
- First Posted Date
- 2003-11-11
- Last Posted Date
- 2007-01-26
- Target Recruit Count
- 240
- Registration Number
- NCT00072683
- Locations
- 🇺🇸
VA Greater Los Angeles Health Care Ctr, Los Angeles, California, United States
🇺🇸University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸Mercury Street Medical, Butte, Montana, United States
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
- Conditions
- First Posted Date
- 2003-10-21
- Last Posted Date
- 2012-05-03
- Target Recruit Count
- 3600
- Registration Number
- NCT00071331
- Locations
- 🇳🇴
Hjertemed.avd. Akershus Universitetssykenhus, Nordbyhagen, Norway
🇳🇴Diakonhjemmets sykehus Oslo, Oslo, Norway
🇺🇸The Heart and Vascular Institute of Florida, St. Petersburg, Florida, United States
Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
- Conditions
- First Posted Date
- 2002-08-14
- Last Posted Date
- 2005-06-24
- Target Recruit Count
- 170
- Registration Number
- NCT00043758
- Locations
- 🇺🇸
Midwest Cardiology Research Foundation, Columbus, Ohio, United States
🇺🇸Medical College of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸Guthrie Clinic, LTD, Sayre, Pennsylvania, United States
Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
- Conditions
- First Posted Date
- 2002-08-14
- Last Posted Date
- 2005-06-24
- Target Recruit Count
- 40
- Registration Number
- NCT00043771
- Locations
- 🇺🇸
Central Cardiology Medical Clinic, Bakersfield, California, United States
🇺🇸Saint Louis University, St. Louis, Missouri, United States
🇺🇸University of California-San Diego, San Diego, California, United States
Drug Development Updates
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