CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Tolvaptandrug
Likely dose
Tolvaptan 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01292304
NCT01292304Phase 4Completed
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Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites

University of Florida·interventional·Posted Feb 9, 2011·Updated Jul 27, 2015

In Brief

A Phase 4 clinical trial evaluating Tolvaptan for Ascites and Cirrhosis. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAscites, Cirrhosis
CountriesUnited States
CollaboratorsOtsuka America Pharmaceutical

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2011
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.4 years ago

Interventions

Tolvaptandrug

Oral administration once daily Dosage will range from 15 mg to 30 mg