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

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.

Timeline

Start

2010-10

Primary completion

2013-05

Completion

2013-05

Outcome

Missed primary endpoint

Stopped (Enrollment): “Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay.”

registry p = 0.9495; Generalized Wilcoxon Test; note: The alpha level was set at 0.05 NCT01227512 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolvaptan	Unknown	60 mg	Oral

Indications