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NCT02025621 · ClinicalTrials.gov registry record · Phase 3
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A Phase 3 study, sponsored by Tenax Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 882
- Enrollment target
NCT02025621: Completed Phase 3 study, sponsored by Tenax Therapeutics.
NCT02025621 is a Phase 3 study that has completed, run by Tenax Therapeutics. The registered enrollment target is 882 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02025621, a Phase 3 study, has completed, sponsored by Tenax Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 882 participants
- Enrollment target
Study 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).
Primary Outcome
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
Interventions
- DRUG Placebo
- DRUG Levosimendan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 882 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT02025621 record still lists
NCT02025621 is an interventional study that assigns participants to a tested intervention. The registered 882 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02025621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02025621 about?
NCT02025621 is a clinical study titled "Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass". 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 (C...
What is the current status of trial NCT02025621?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 882 participants. The study started on 2014-07. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02025621?
The interventions under investigation include: Placebo (DRUG), Levosimendan (DRUG).
Who is sponsoring clinical trial NCT02025621?
This trial is sponsored by Tenax Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02025621's enrollment target sits among peer trials
882 366th of 2000 higher than 1,634 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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