CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 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/NCT01439009
NCT01439009Phase 4Completed
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A Multi-center,_double-blind,_pararel-group Comparison Trial to Investigate the Effect of Short-term Administration of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients (Phase_4 Study)

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Sep 22, 2011·Updated Oct 22, 2019

In Brief

A Phase 4 clinical trial evaluating Tolvaptan and Placebo of tolvaptan for Heart Failure. Completed, enrolled 100 participants across 8 sites.

Detailed Summary

One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2011
Enrollment StartSep 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.8 years ago

Interventions

Tolvaptandrug

Once-daily oral administration of one tolvaptan 15 mg tablet in the morning

Placebo of tolvaptandrug

Once-daily oral administration of one placebo tablet in the morning