CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 882 enrolled
Drug / intervention
Levosimendan +1 moredrug
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.

Search/NCT02025621
NCT02025621Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

Tenax Therapeutics, Inc.·interventional·Posted Jan 1, 2014·Updated Jun 21, 2018

In Brief

A Phase 3 clinical trial evaluating Levosimendan and Placebo for Coronary Artery Bypass Grafting and 2 related conditions. Completed, enrolled 882 participants across 60 sites in 2 countries.

Detailed Summary

A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 1, 2014
Enrollment StartJul 1, 2014
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.5 years ago

Interventions

Levosimendandrug

Placebodrug

matching placebo