# Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

> **NCT00428948** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 1445 (actual)

## Conditions studied

- Polycystic Kidney Disease, Autosomal Dominant

## Interventions

- **DRUG:** Tolvaptan
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00428948
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-01
- **Primary completion:** 2012-01
- **Final completion:** 2012-01
- **Target enrollment:** 1445 (ACTUAL)
- **Last updated:** 2017-07-02

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00428948

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00428948, "Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT00428948. Licensed CC0.

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