Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

NCT01919801 ↗

Phase 3 Completed 118 enrolled Shire PPD Development, LP · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.

Timeline

Start: 2013-12-02
Primary completion: 2015-08-22
Completion: 2015-08-22

Outcome

Missed primary endpoint

paper We observed no difference in time to meeting discharge criteria between groups (median, 4.0 hours in each group; P = .63). PMID 28552382 ↗

paper Icatibant was no more efficacious than placebo in at least moderately severe ACE-I-induced angioedema of the upper airway. PMID 28552382 ↗

Publications

Results Sinert R, Levy P, Bernstein JA, Body R, Sivilotti MLA, Moellman J, Schranz J, Baptista J, Kimura A, Nothaft W; CAMEO study group. Randomized Trial of Icatibant for Angiotensin-Converting Enzyme Inhibitor-Induced Upper Airway Angioedema. J Allergy Clin Immunol Pract. 2017 Sep-Oct;5(5):1402-1409.e3. doi: 10.1016/j.jaip.2017.03.003. Epub 2017 May 25.

Drugs