A phase 3 study of icatibant in adults with ACE-I-Induced Angioedema
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety and Efficacy of Icatibant as a Treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults
IRAS ID
159169
Contact name
John Hollingworth
Contact email
Sponsor organisation
Shire Orphan Therapies, Inc
Eudract number
2014-001213-12
Clinicaltrials.gov Identifier
Research summary
Angiotensin-converting enzyme inhibitors (ACE-I) are medicines commonly given to patients for the treatment of high blood pressure, heart conditions, diabetes, and chronic kidney disease. Approximately 35 million patients take ACE inhibitors worldwide. A side effect of ACE-I therapy is angioedema, which is a swelling similar to hives, but deep under the skin instead of on the surface. People with ACE-I-induced angioedema can have symptoms which include swelling of the head or neck area, including the lips, mouth, tongue, and throat, which may cause breathing problems.
There are no approved drug treatments for ACE-I-induced angioedema. Medicines for allergic reactions such as antihistamines, corticosteroids and epinephrine are commonly administered but because ACE-I angioedema is not a histamine-mediated allergic reaction, their effectiveness when used in this condition is limited.
This study is being done to show that icatibant works better than placebo in resolving ACE-I-induced angioedema. A placebo is a look-alike treatment that has no active drug in it.
This is a double-blind study, which means neither the patient nor the Study Doctor will know which study drug will be assigned (except in cases of emergency). Participants who provide written consent and meet all eligibility criteria will have a 50% chance of receiving icatibant and a 50% chance of receiving placebo.
The study will include screening tests to see if the participant is suitable. They will then be assigned treatment and given the injection under the skin of the belly. Following treatment the participant will be monitored continuously for at least 8 hours. The participant can then be discharged if they meet study criteria. The participant will receive a follow up phone call approximately 3 days after they receive the injection.The study involves: physical exams, electrocardiogram (ECG; measures heart electrical activity), vital signs, blood and urine tests, and investigator assessments.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1070
Date of REC Opinion
13 Aug 2014
REC opinion
Further Information Favourable Opinion