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Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

NCT01574248 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-02-17

Study results available
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Summary

Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life-threatening condition that causes swelling of the face and other body parts. This study will evaluate the effectiveness of the drug HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the condition.

Conditions

  • ACE Inhibitor-associated Angioedema

Interventions

DRUG

icatibant

Subcutaneous at time 0 and 6 hours

OTHER

Placebo

Subcutaneous at time 0 and 6 hours

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Nancy J. Brown, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-09-30
Completion
2016-02-29

Countries

  • United States

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 NCT01574248 on ClinicalTrials.gov