NCT01214421

Tolvaptan Extension Study in Participants With ADPKD

Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,083 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.

Conditions

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

Type	Name	Description
DRUG	Tolvaptan	Tablets of 15 or 30 mg

Timeline

• Start date: 2010-05-26
• Primary completion: 2016-02-29
• Completion: 2016-02-29
• First posted: 2010-10-05
• Last updated: 2021-10-25
• Results posted: 2021-10-25

Locations

97 sites across 13 countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Romania, Russia, United Kingdom

Regulatory

• FDA-regulated drug study