At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 118 enrolled
Drug / intervention
Icatibant +1 moredrug
Likely dose
Icatibant 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety & Efficacy of Icatibant as a Treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults
In Brief
A Phase 3 clinical trial evaluating Icatibant and Placebo for Angiotensin Converting Enzyme Inhibitor Induced Angioedema. Completed, enrolled 118 participants across 55 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Israel, United Kingdom, United States
CollaboratorsPPD Development, LP
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartDec 2013
Primary CompletionAug 2015
TodayJul 2026
First PostedAug 9, 2013
Enrollment StartDec 2, 2013
Primary CompletionAug 22, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.9 years ago
Interventions
Icatibantdrug
Single dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema
Placebodrug