Clinical trial

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

NCT00184548 · Novo Nordisk A/S, Industry · Terminated

Key facts

NCT number NCT00184548
Title Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
Official title A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment
Acronym CONTROL
Lead sponsor Novo Nordisk A/S, Industry
Status Terminated
Phase Phase 3
Study type Interventional
Conditions Acquired Bleeding Disorder, Trauma
Intervention type Drug
Interventions eptacog alfa (activated), placebo
Enrollment 554
Start date Oct 1, 2005
Primary completion Sep 1, 2008
Completion Sep 1, 2008
First posted Sep 16, 2005
Last update posted Jun 25, 2014
Countries Brazil, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland and 2 more

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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