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)
Phase of Trial: Phase III
Latest Information Update: 31 Mar 2017
At a glance
- Drugs Tolvaptan (Primary)
- Indications Autosomal dominant polycystic kidney disease
- Focus Therapeutic Use
- Acronyms TEMPO 4-4; TEMPO 4/4
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 31 Mar 2017 Primary endpoint (Percent Change in Total Kidney Volume (TKV)) has not been met, according to results published in the Nephrology Dialysis Transplantation Journal.
- 31 Mar 2017 Results published in the Nephrology Dialysis Transplantation Journal.
- 04 May 2016 Status changed from active, no longer recruiting to completed.