Clinical Trial: Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
Brief Summary:
This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema.
This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.
Detailed Summary:
Sponsor: Technische Universität München
Current Primary Outcome: time of resolution [ Time Frame: 07/2013 until 12/2014 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Technische Universität München
Dates:
Date Received: April 26, 2013
Date Started: November 2013
Date Completion: September 2018
Last Updated: April 28, 2016
Last Verified: April 2016