Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

Summary

To evaluate the efficacy and safety of Tolvaptan 7.5mg and 15mg in treatment of patients with cirrhosis ascites who fail to response adequately to treatment with common diuretics.

Timeline

Start

2010-10

Primary completion

2012-05

Completion

2012-07

Outcome

Met primary endpoint

paper The administration of 7.5 or 15 mg/day tolvaptan significantly decreased body weight from baseline on day 7 of treatment compared to that with placebo treatment PMID 33213378 ↗

Publications

• Tang J, Wang Y, Han T, Mao Q, Cheng J, Ding H, Shang J, Zhang Q, Niu J, Ji F, Chen C, Jia J, Jiang X, Lv N, Gao Y, Wang Z, Wei Z, Chen Y, Zeng M, Mao Y. Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial. BMC Gastroenterol. 2020 Nov 19;20(1):391. doi: 10.1186/s12876-020-01536-0.
• Wang S, Zhang X, Han T, Xie W, Li Y, Ma H, Liebe R, Weng H, Ding HG. Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia. BMC Gastroenterol. 2018 Sep 4;18(1):137. doi: 10.1186/s12876-018-0857-0.

Drugs

Indications