drugset / Trial / NCT01154361

AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

NCT01154361

Phase 2 Completed Technical University of Munich
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter study recruiting patients with angioedema induced by ACEI. Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which the investigators have been previously treated in the investigators centers with current "standard" therapy (250 mg methylprednisolon and 2 mg clemastine). In cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary. Rescue medication and intervention.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clemastine Small molecule 2 mg Intravenous
Comparator Cortisone acetate Other / unclassified Intravenous
Subject Icatibant Peptide 30 mg Subcutaneous

Indications