Trial Profile
A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Mar 2023
Price :
$35
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At a glance
- Drugs Tolvaptan (Primary)
- Indications Autosomal dominant polycystic kidney disease
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 01 Mar 2023 Results assessing the clinical pattern and hepatic safety profile of tolvaptan in patients with autosomal dominant polycystic kidney disease from NCT00428948 (TEMPO 3:4), NCT01214421 (TEMPO 4:4), NCT02160145 (REPRISE), and NCT02251275 (long-term extension) studies, published in the American Journal of Kidney Diseases.
- 18 Jan 2019 Status changed from active, no longer recruiting to completed.
- 04 Dec 2018 This trial was completed in Czech Republic (end date: 2018-11-09), according to European Clinical Trials Database