NCT01227512

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia

Phase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA(r) (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized With Dilutional Hyponatremia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of hyponatremia in hospitalized patients.

Conditions

• Hyponatremia
• Dilutional Hyponatremia
• Inappropriate ADH Syndrome

Interventions

Type	Name	Description
DRUG	tolvaptan	15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response.
OTHER	Fluid Restriction	Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response. Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose"

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-10-25
• Last updated: 2014-10-30
• Results posted: 2014-10-17

Locations

56 sites across 1 country: United States