Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Shire
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Bradykinin; Icatibant; Kininogens

Criteria

Inclusion Criteria:

• The subject has ongoing angioedema while taking an ACE inhibitor.

• The subject is between 18 and 80 years of age.

Exclusion Criteria:

• The subject has had angioedema while not taking an ACE inhibitor.

• The subject's angioedema only involves the bowel.

• The subject is known to be pregnant or has a positive urine pregnancy test.

• The subject has started on an oral contraceptive within the last 6 months.