Trials / Completed
CompletedNCT00903604
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- 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 the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac 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
- Aortic Root or Ascending Aortic Aneurysm Repair Surgery
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AP214 | Three 10-minutes infusions of sequential ascending dosages of AP214 |
| DRUG | Placebo | Three 10-minutes infusions of isotonic saline solution |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2010-06-01
- Completion
- 2010-06-01
- First posted
- 2009-05-18
- Last updated
- 2011-05-17
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00903604. Inclusion in this directory is not an endorsement.