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

NCT01227512 · clinicaltrials.gov ↗

PHASE3

Phase

TERMINATED

Status

124

Enrollment

INDUSTRY

Sponsor class

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

Conditions

Hyponatremia
Dilutional Hyponatremia
Inappropriate ADH Syndrome

Interventions

DRUG: tolvaptan
OTHER: Fluid Restriction

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.