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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Kath. Klinikum Bochum, Med. Klinik III
Bochum, Germany
Ludwig-Maximilian-Universität
München, Germany
Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
München, Germany
Universitätsklinikum Ulm, HNO
Ulm, Germany
time of resolution
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.
Time frame: 07/2013 until 12/2014
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