Trial Profile
A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 02 May 2023
Price :
$35
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At a glance
- Drugs Tolvaptan (Primary)
- Indications Autosomal dominant polycystic kidney disease
- Focus Registrational; Therapeutic Use
- Acronyms REPRISE
- Sponsors Otsuka Pharmaceutical; Otsuka Pharmaceutical Development & Commercialization
- 24 Mar 2023 Results deriving plasma samples from NCT02160145 for comparing changes in the plasma BA profiles in TOL-treated patients with and without ALT elevations.presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
- 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.
- 07 Jan 2019 Mexico was planned location as per European Clinical Trials Database.