International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia

Phase 3 Completed 111 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

NaSingle-groupOpen-labelTreatment

Summary

This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.

Timeline

Start: 2004-05
Primary completion: 2009-10
Completion: 2009-10

Publications

Results Berl T, Quittnat-Pelletier F, Verbalis JG, Schrier RW, Bichet DG, Ouyang J, Czerwiec FS; SALTWATER Investigators. Oral tolvaptan is safe and effective in chronic hyponatremia. J Am Soc Nephrol. 2010 Apr;21(4):705-12. doi: 10.1681/ASN.2009080857. Epub 2010 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolvaptan	Small molecule	15 mg	Oral
Subject	Tolvaptan	Small molecule	30 mg	Oral
Subject	Tolvaptan	Small molecule	60 mg	Oral

Indications

No indication recorded.