Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517582
Status:
TERMINATED
Last Update Posted:
2015-12-18
First Post:
2007-08-15
Brief Title:
Bradykinin Receptor Blocker in ACE Inhibitor-associated Angioedema
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Study of a Bradykinin Receptor Blocker in Angiotensin Converting Enzyme Inhibitor-Associated Angioedema
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped to allow initiation of a mult-center study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HL079184-Specific Aim 1 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01HL079184 |
| R01HL079184 | NIH | None | None |