Tolvaptan Open-Label Pilot Efficacy, Tolerability and Safety Study in ADPKD (TEMPO 2/4)

This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with ADPKD.


Study Type: InterventionalAllocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney Disease
Enrollment: 46
Study Start Date: December 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Fixed Low Dose
- Experimental: Fixed High Dose
- Experimental: Titration