Bradykinin Receptor Blocker in ACE Inhibitor-associated Angioedema
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ClinicalTrials.gov Identifier: NCT00517582 |
Recruitment Status :
Terminated
(This study was stopped to allow initiation of a mult-center study)
First Posted : August 17, 2007
Last Update Posted : December 18, 2015
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Condition or disease | Intervention/treatment | Phase |
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Angioneurotic Edema | Drug: HOE-140 Other: Placebo | Phase 1 |
People who take ACE inhibitors may develop angioedema, a condition that causes itchy and painful swelling beneath the skin around the eyes, lips, tongue, throat, hands, or feet. In severe cases, the throat may swell, obstructing the airway and leading to breathing difficulty. ACE inhibitors prevent the breakdown of a natural chemical in the body called bradykinin. Increased levels of bradykinin, which can cause swelling, may contribute to the development of angioedema. Blocking bradykinin receptor cells prevents bradykinin from initiating swelling and may lead to a possible decrease in angioedema symptoms. The purpose of this study is to evaluate the effectiveness of HOE-140, a bradykinin receptor blocker, at reducing symptoms in people with ACE inhibitor-associated angioedema.
This study will enroll people admitted to the emergency room or hospital who have a severe case of ACE inhibitor-associated angioedema. Participants will be randomly assigned to receive an injection of either HOE-140 or placebo. Initially, participants will undergo an electrocardiogram to measure the electrical activity of the heart. Then blood pressure measurements, blood collection, a physical exam to determine the extent and duration of swelling, and photographs of the swelling will occur at 2, 4, 8, 16, and 24 hours following the start of treatment. Questionnaires will be completed by study staff and participants to assess changes in angioedema symptoms and the extent of swelling. Participants will remain in the hospital for 24 to 48 hours, depending on the severity of their symptoms. Blood will be collected at a follow-up visit that will occur 7 days after the resolution of angioedema symptoms.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Study of a Bradykinin Receptor Blocker in Angiotensin Converting Enzyme Inhibitor-Associated Angioedema |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
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Experimental: HOE-140
Administration of HOE-140 (icatibant) 30 mg at time 0 and at 6 hours
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Drug: HOE-140
Subcutaneous at time 0 and 6 hours
Other Name: icatibant |
Placebo Comparator: Placebo
Administration of placebo at time 0 and 6 hours
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Other: Placebo
Subcutaneous at time 0 and 6 hours |
- Time to resolution of angioedema, as defined as the time interval between when the participant first noted the onset of symptoms and when there is no objective evidence of angioedema by physical examination [ Time Frame: Measured at follow-up visit 7 days following resolution of angioedema ]
- Length of hospital stay, admission to the intensive care unit, requirement for intubation, duration of intubation, use of steroids, use of histamine receptor type 1 (H1) and H2 blockers, use of epinephrine, and blood pressure levels [ Time Frame: Measured at follow-up visit 7 days following resolution of angioedema ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ambulatory
- ACE inhibitor-associated angioedema, as defined as swelling of the lips, pharynx, or face while taking an ACE inhibitor, no history of angioedema while not taking an ACE inhibitor, and no evidence of abnormal C1 inhibitor concentration or abnormal complement levels. People with possible cases of ACE inhibitor-associated bowel edema will not be enrolled.
- If female, must be postmenopausal for at least 1 year prior to study entry, undergone surgical sterilization, or willing to use an effective form of birth control and take a pregnancy test daily for the duration of the study
Exclusion Criteria:
- Pregnant or breastfeeding
- Started taking birth control pills in the 6 months prior to study entry

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517582
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37205 |
Principal Investigator: | Nancy J. Brown, MD | Vanderbilt University Medical Center |
Responsible Party: | Nancy J. Brown, Professor, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00517582 |
Other Study ID Numbers: |
495 R01HL079184 ( U.S. NIH Grant/Contract ) HL079184-Specific Aim 1 |
First Posted: | August 17, 2007 Key Record Dates |
Last Update Posted: | December 18, 2015 |
Last Verified: | December 2015 |
ACE Inhibitor Angioedema Bradykinin Swelling |
Angioedema Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Icatibant Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Bradykinin B2 Receptor Antagonists Bradykinin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors |