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AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

NCT01154361 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2011-12-23

No results posted yet for this study

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.

Conditions

  • Angioedema

Interventions

DRUG

Icatibant (subcutaneous) and plazebo (intravenous)

DRUG

Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Murat Bas, Dr. · Klinikum rechts der Isar, Hals-Nasen-Ohrenklinik, Ismaninger Str. 22 81675 München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01154361 on ClinicalTrials.gov