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Clinical Trials/EUCTR2012-001670-28-DE
EUCTR2012-001670-28-DE
Active, not recruiting
Phase 1

Angiotensin Converting Enzyme Inhibitor (ACE) Induced AngioedemaBERINERTRandomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema - BERINERT

Medizinische Fakultät der Technischen Universität München0 sites52 target enrollmentAugust 14, 2012
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ConditionsAngiotensin – Converting – Enzyme – Inhibitors (ACEi) are used in the treatment of several types of cardiovascular and renal diseases. A known side effect of ACEi are angioedema of the head and neck region. These can lead to severe dyspnoea and the need for intubation and are thought to be bradykinin mediated. Up until now there is no study-evaluated conservative therapeutic concept for the treatment of these patients.MedDRA version: 18.1Level: HLTClassification code 10002425Term: AngioedemasSystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsBerinert

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Angiotensin – Converting – Enzyme – Inhibitors (ACEi) are used in the treatment of several types of cardiovascular and renal diseases. A known side effect of ACEi are angioedema of the head and neck region. These can lead to severe dyspnoea and the need for intubation and are thought to be bradykinin mediated. Up until now there is no study-evaluated conservative therapeutic concept for the treatment of these patients.
Sponsor
Medizinische Fakultät der Technischen Universität München
Enrollment
52
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 14, 2012
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medizinische Fakultät der Technischen Universität München

Eligibility Criteria

Inclusion Criteria

  • •?Written informed consent to participate in the study and ability to fulfil all study requirements
  • •?Male or female patients aged ?18 years
  • •?Patients with ACE induced angioedema (grade II\-III in at least one severity scale) with imminent airway obstruction admitted to an Emergency department
  • •?Patient is being treated with ACEi
  • •?Patient must have acute angioedema attack caused by ACEi
  • •?Treatment should be administered within 10 hours after onset of the angioedema
  • •?Patients with angioedema of the head and/or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
  • •?Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •?Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1\-inhibitor deficiency, allergic oedema, anaphylaxis, insect bite, trauma, abscess, local inflammation,
  • •?local tumour, post\-operative or post\-radiogenic oedema, salivary gland disorders
  • •?Participation in a clinical study in the past 30 days
  • •?Patients with simultaneous itchiness of skin (acute urticaria)
  • •?Patients with a history of angioedema before taking ACEI
  • •?History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
  • •?Pregnancy and/or breastfeeding
  • •?Mental retardation of the patient with restriction of general judgment and awareness
  • •?History of drug abuse (including alcohol and alcoholic liver disorders)
  • •?Potentially unreliable patients

Outcomes

Primary Outcomes

Not specified

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