A multicenter, randomized, double-blind study with 2 groups as prove of concept for the treatment of ACE induced angioedema with subcutaneous Icatibant - AMACE

• Conditions: The study objective is to assess the efficacy and safety of the Bradykinin-2 (BK-2) receptor antagonist Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which we have been previously treated in our centers with current standard” therapy (250 mg methylprednisolon and 2 mg clemastine).

• Registration Number: EUCTR2009-015410-22-DE
• Lead Sponsor: Medizinische Fakultaet der Technischen Universitaet Muenchen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-03
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Age ³ 18 years<96 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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, local 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.
akte heart disease NYHA-Clssification 3-4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified