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Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery

NCT00903604 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-05-17

No results posted yet for this study

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

DRUG

AP214

Three 10-minutes infusions of sequential ascending dosages of AP214

DRUG

Placebo

Three 10-minutes infusions of isotonic saline solution

Sponsors & Collaborators

  • Action Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Daniel Steinbrüchel, Professor · Department of Cardiac and Thoracic Surgery, Copenhagen University Hospital, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903604 on ClinicalTrials.gov