Drug & intervention

tolvaptan

RxCUI 358257

Clinical trials27
Recruiting0
Related conditions20
Synonyms1

RxNorm ingredient and formulation relationships

Source-verified product relationships. Every strength, delivery form and RxCUI remains a separate clinical concept.

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Background context

Tolvaptan

Tolvaptan, sold under the brand name Samsca among others, is an aquaretic drug that functions as a selective, competitive vasopressin receptor 2 (V2) antagonist used to treat hyponatremia (low blood sodium levels) associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH). Tolvaptan was approved by the U.S. Food and Drug Administration (FDA) on May 19, 2009, and is sold by Otsuka Pharmaceutical Co. under the trade name Samsca. Tolvaptan, as Jynarque, was granted approval for medical use in the United States in April 2018. The U.S. Food and Drug Administration (FDA) granted tolvaptan a fast track designation for clinical trials investigating its use for the treatment of polycystic kidney disease. The FDA granted Jynarque an orphan drug designation in April 2012, for the treatment of autosomal dominant polycystic kidney disease. Tolvaptan is available as a generic medication.

Background only. Canonical identity remains RxNorm; clinical-trial relationships come from ClinicalTrials.gov.

Clinical trials

27 shown
A Study of HRS-9057 in Patients With Heart Failure and Volume OverloadNCT06506994 · 2024-08-16
COMPLETED
Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAHNCT05569655 · 2021-04-06
UNKNOWN
Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation PatientsNCT05408104 · 2019-03-28
COMPLETED
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume OverloadNCT03255226 · 2018-03-07
COMPLETED
Tolvaptan for Advanced or Refractory Heart FailureNCT02959411 · 2016-10-01
TERMINATED
Regional Tolvaptan RegistryNCT02666651 · 2016-05-01
UNKNOWN
Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart FailureNCT02606253 · 2016-02-01
COMPLETED
Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying RespondersNCT02476409 · 2015-07-01
COMPLETED
Aquaresis Utility for Hyponatremic Acute Heart Failure StudyNCT02183792 · 2014-12-01
COMPLETED
Tolvaptan/Ultrafiltration in the Treatment of Acute Heart FailureNCT01863511 · 2013-05-01
COMPLETED
Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart FailureNCT02352285 · 2012-12-01
TERMINATED
Tolvaptan for Hyponatremia in Cirrhotic Patients With AscitesNCT01716611 · 2012-11-01
UNKNOWN
Targeting Acute Congestion With Tolvaptan in Congestive Heart FailureNCT01644331 · 2012-10-01
COMPLETED
The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot StudyNCT01663662 · 2012-08-01
WITHDRAWN
Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac EdemaNCT01651156 · 2012-07-01
COMPLETED
Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart FailureNCT01618448 · 2012-07-01
COMPLETED
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure PatientsNCT01439009 · 2011-09-01
COMPLETED
Tolvaptan for In-hospital HyponatremiaNCT01386372 · 2011-06-01
TERMINATED
Pilot Study of Using Copeptin to Predict Response to TolvaptanNCT01346072 · 2011-04-01
COMPLETED
Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical PracticeNCT01228682 · 2010-10-01
UNKNOWN
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart FailureNCT00132886 · 2004-12-01
COMPLETED
Study of Ascending Levels of Tolvaptan in HyponatremiaNCT00201994 · 2003-11-01
COMPLETED
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With TolvaptanNCT00071331 · 2003-09-01
COMPLETED
"SALT Trial" Study of Ascending Levels of Tolvaptan in HyponatremiaNCT00072683 · 2003-04-01
COMPLETED
Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure PatientsNCT00043758 · 2002-07-01
COMPLETED
Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure PatientsNCT00043771 · 2002-05-01
COMPLETED
Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)NCT01733134
WITHDRAWN

Leading sponsors

Drug identity and terminology: RxNorm. Trial relationships: ClinicalTrials.gov.