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: 11 Jun 2019
Price : $35 *
At a glance
- Drugs Tolvaptan (Primary)
- Indications Autosomal dominant polycystic kidney disease
- Focus Registrational; Therapeutic Use
- Acronyms TEMPO 4-4; TEMPO 4/4
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 07 Jan 2019 Results of population pharmacokinetic analyses and model validation of Tolvaptan from 5 phase II trials (NCT00413777, NCT01210560, NCT01214421 and NCT02160145) published in the Journal of Clinical Pharmacology.
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History