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

> **NCT01227512** · PHASE3 · TERMINATED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 124 (actual)

## Conditions studied

- Hyponatremia
- Dilutional Hyponatremia
- Inappropriate ADH Syndrome

## Interventions

- **DRUG:** tolvaptan
- **OTHER:** Fluid Restriction

## Key facts

- **NCT ID:** NCT01227512
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2010-10
- **Primary completion:** 2013-05
- **Final completion:** 2013-05
- **Target enrollment:** 124 (ACTUAL)
- **Why stopped:** Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay.
- **Last updated:** 2014-10-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01227512

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01227512, "Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01227512. Licensed CC0.

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