NCT00628264

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Action Pharma A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery
• Coronary Artery Bypass Grafting
• Valve Surgery
• Kidney Injury

Interventions

Type	Name	Description
DRUG	AP214	Three AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
DRUG	Placebo	Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-03-05
• Last updated: 2009-06-01

Locations

2 sites across 1 country: United States