Study of Ascending Levels of Tolvaptan in Hyponatremia

NCT00201994 ↗

Phase 3 Completed 243 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Pharmaceutical Co., Ltd. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal and to characterize and quantify the potential clinical benefits of this treatment.

Timeline

Start: 2003-11-01
Primary completion: 2005-07-01
Completion: 2005-07-01

Publications

Lee MY, Kang HJ, Park SY, Kim HL, Han E, Lee EK. Cost-effectiveness of tolvaptan for euvolemic or hypervolemic hyponatremia. Clin Ther. 2014 Sep 1;36(9):1183-94. doi: 10.1016/j.clinthera.2014.07.010. Epub 2014 Aug 21.
Cardenas A, Gines P, Marotta P, Czerwiec F, Oyuang J, Guevara M, Afdhal NH. Tolvaptan, an oral vasopressin antagonist, in the treatment of hyponatremia in cirrhosis. J Hepatol. 2012 Mar;56(3):571-8. doi: 10.1016/j.jhep.2011.08.020. Epub 2011 Oct 23.
Schrier RW, Gross P, Gheorghiade M, Berl T, Verbalis JG, Czerwiec FS, Orlandi C; SALT Investigators. Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N Engl J Med. 2006 Nov 16;355(20):2099-112. doi: 10.1056/NEJMoa065181. Epub 2006 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolvaptan	Small molecule	60 mg	Oral

Indications

No indication recorded.