drugset / Trial / NCT00628264

Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery

NCT00628264 ↗

Phase 2 Terminated 75 enrolled Action Pharma A/S
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.

Timeline

Start
2008-03
Primary completion
2009-06
Completion
2009-06

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated due to a considerably lower recruitment rate than anticipated”

Drugs

EvaluationDrugModalityDoseRoute
Subject MODIMELANOTIDE Protein / enzyme biologic — —