Completed PHASE3 INTERVENTIONAL 3-arm NCT01349348

Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

A Randomized, Double-blinded, Multicenter, Placebo Controlled, Parallel Designed Study, to Evaluate the Efficacy and Safety of Tolvaptan Tablet in Treatment of Patients With Cirrhosis Ascites, Using Diuretics as Initial Treatment

Sponsor: Otsuka Beijing Research Institute

Conditions Ascites Hepatic Cirrhosis

Interventions Tolvaptan placebo

Updated 5 times since 2017 Last updated: Oct 10, 2012 Started: Oct 31, 2010 Primary completion: May 31, 2012 Completion: Jul 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01349348, this PHASE3 trial focuses on Ascites and Hepatic Cirrhosis and remains completed. Sponsored by Otsuka Beijing Research Institute, it has been updated 5 times since 2010, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Oct 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Otsuka Beijing Research Institute

Data source: Otsuka Beijing Research Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Shanghai, China