CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Tolvaptan +1 moredrug
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/NCT01199198
NCT01199198Phase 4Completed
CompareCT.gov

Randomized Placebo-Controlled Trial of Tolvaptan in Hyponatremic Patients With Cancer

M.D. Anderson Cancer Center·interventional·Posted Sep 10, 2010·Updated Sep 23, 2020

In Brief

A Phase 4 clinical trial evaluating Tolvaptan and Placebo for Advanced Cancers. Completed, enrolled 52 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancers
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Development & Commercialization, Inc.

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2010
Enrollment StartMay 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.8 years ago

Interventions

Tolvaptandrug

Starting dose 15 mg by mouth once a day for 14 days.

Placebodrug

Placebo by mouth once a day for 14 days.