Clinical Trials Directory

Trials / Terminated

TerminatedNCT00154427

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
172 (actual)
Sponsor
Novo Nordisk A/S · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

Conditions

Interventions

TypeNameDescription
DRUGactivated recombinant human factor VII

Timeline

Start date
2004-08-01
Primary completion
2007-11-01
Completion
2007-11-01
First posted
2005-09-12
Last updated
2017-01-12

Locations

63 sites across 14 countries: United States, Argentina, Brazil, Denmark, France, Germany, India, Italy, Malaysia, Singapore, South Africa, Spain, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT00154427. Inclusion in this directory is not an endorsement.