# A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

> **NCT01280721** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Co., Ltd.** · enrollment: 135 (actual)

## Conditions studied

- Autosomal Dominant Polycystic Kidney Disease （ADPKD)

## Interventions

- **DRUG:** tolvaptan

## Key facts

- **NCT ID:** NCT01280721
- **Lead sponsor:** Otsuka Pharmaceutical Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-11
- **Primary completion:** 2014-08
- **Final completion:** 2014-08
- **Target enrollment:** 135 (ACTUAL)
- **Last updated:** 2019-01-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01280721

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01280721, "A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01280721. Licensed CC0.

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