Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT01154361
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 18 \<85 years
* Patient is currently treated with an ACEI
* Patient must have acute angioedema attack caused by an ACEI
* Treatment should be administrated within 10 hrs after onset by an ACEI
* Patient with angioedema of head and /or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
* At least one moderate to severe severe angioedema symptom as assessed by the investigator, requiring a medical intervention
* Signed written Informed Consent Form
Exclusion Criteria:
* Diagnosis of angioedema that was not caused by ACEI: e.g. hereditary angioedema (C1-INH deficiency), allergy, anaphylaxis, insect bite, trauma, infection, abscess, tumor, post-radiation or post-operative or processes related to salivary glands and others where it is unlikely that the ACEI is causing the angioedema
* Participation in a clinical trial of another investigational medicinal product (IMP) within 30 days
* Patients with acute urticaria
* Patients with a medical history of any angioedema before taking an ACEI
* Patients with an acute rash or hives in the face or somewhere else
* Unstable angina or acute myocardial infarction
* Acute heart failure
* Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial
* Pregnancy and/or breast-feeding
* Mental condition rendering the patients, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study;
* Unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for the follow-up visit, or unlikely to complete the study for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT01154361
Study Brief:
Protocol Section:
NCT01154361