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

Medizinische Fakultaet der Technischen Universitaet Muenchen0 个研究点目标入组 30 人开始时间: 2010年2月3日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•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

•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

发起方

Medizinische Fakultaet der Technischen Universitaet Muenchen