Bradykinin Receptor Blocker in ACE Inhibitor-associated Angioedema

NCT00517582 | Terminated Phase 1

• 3 other identifiers: 495R01HL079184HL079184-Specific Aim 1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Angioneurotic Edema

Keywords

ACE Inhibitor; Angioedema; Bradykinin; Swelling

Outcome Measures

Primary Outcomes (1)

• 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

  Measured at follow-up visit 7 days following resolution of angioedema

Secondary Outcomes (1)

• 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

  Measured at follow-up visit 7 days following resolution of angioedema

Study Arms (2)

HOE-140

EXPERIMENTAL

Administration of HOE-140 (icatibant) 30 mg at time 0 and at 6 hours

Drug: HOE-140

Placebo

PLACEBO COMPARATOR

Administration of placebo at time 0 and 6 hours

Other: Placebo

Interventions

HOE-140 DRUG

Subcutaneous at time 0 and 6 hours

Also known as: icatibant

HOE-140

Placebo OTHER

Subcutaneous at time 0 and 6 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding
• Started taking birth control pills in the 6 months prior to study entry

Sponsors & Collaborators

• Vanderbilt University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Angioedema

Interventions

icatibant

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nancy J. Brown, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)