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Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema

NCT01843530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-11-24

No results posted yet for this study

Summary

This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema.

This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.

Conditions

  • Acute ACE-induced Angioedema

Interventions

DRUG

Berinert

DRUG

Clemastin

DRUG

Cortisone acetate

DRUG

NaCl

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Murat Bas, Dr. · Klinikum rechts der Isar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-10-05
Completion
2019-09-30

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 NCT01843530 on ClinicalTrials.gov