At a glance
ClinicalIndex Comparison RecordPhase 3Completed
Drug / intervention
Tolvaptandrug
Likely dose
Not stated in 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.
Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 21, 2003·Updated May 3, 2012
In Brief
A Phase 3 clinical trial evaluating Tolvaptan for Congestive Heart Failure. Completed, across 378 sites in 18 countries.
Detailed Summary
The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesArgentina, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, Norway, Poland, Romania, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2003
First PostedOct 2003
Primary CompletionJul 2006
TodayJul 2026
First PostedOct 21, 2003
Enrollment StartSep 1, 2003
Primary CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.7 years ago
Interventions
Tolvaptandrug