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 autosomal dominant polycystic kidney disease (ADPKD).
Phase of Trial: Phase II
Latest Information Update: 07 Jan 2019
At a glance
- Drugs Tolvaptan (Primary)
- Indications Autosomal dominant polycystic kidney disease
- Focus Adverse reactions
- Acronyms TEMPO 2/4
- 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.
- 27 Feb 2017 New trial record
- 20 Feb 2017 Results of three phase II studies published in the Journal of Clinical Pharmacology