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

NCT00628264 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2009-06-01

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Action Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Thomas M Beaver, MD, MPH · Division of Thoracic and Cardiovascular Surgery , University of Florida College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

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 NCT00628264 on ClinicalTrials.gov