Phase
Condition
Allergies & Asthma
Allergy
Hives (Urticaria)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, 18 years of age or older.
- Patient is currently being treated with an ACE inhibitor.
- Patient presenting with an ACE inhibitor-induced angioedema attack of the head and/orneck region within 12 hours of onset (must be sufficiently less than 12 hours to allowstudy drug to be given with 12 hours of attack onset).
- Angioedema must be considered at least moderate in severity for at least one of thefour angioedema-associated airway symptoms (difficulty breathing, difficultyswallowing, voice changes, tongue swelling).
- Patient must have voluntarily signed an Institutional Review Board/Independent EthicsCommittee-approved informed consent form after all relevant aspects of the study havebeen explained and discussed with the patient.
- Females must have a negative urine pregnancy test prior to administration of the studymedication, with the exception of those females who have had a total hysterectomy orbilateral oophorectomy, or who are 2 years post-menopausal.
Exclusion
Exclusion Criteria:
- Patient has a diagnosis of angioedema of other etiology (eg, hereditary or acquiredangioedema, allergic angioedema [eg, food, insect bite or sting, evident clinicalresponse to antihistamines and/or corticosteroids], anaphylaxis, trauma, abscess orinfection or associated disease, local inflammation, local tumor, post-operative orpost-radiogenic edema, salivary gland disorders, other [non-ACE inhibitor]drug-induced angioedema).
- Patients with a family history of recurrent angioedema.
- Patients who have had a previous episode(s) of angioedema while not on ACE inhibitortherapy.
- Patients with acute urticaria (itchy, erythematous wheals).
- Patients who have an intervention to support the airway (eg, intubation, tracheotomy,cricothyrotomy) due to the current attack of angioedema.
- Patient has any of the following vascular conditions that, in the judgment of theinvestigator, would be a contraindication to participation in the study.
- Unstable angina pectoris or acute myocardial ischemia
- Hypertensive urgency or emergency (diastolic blood pressure [DBP] >120 mm Hg orsystolic blood pressure [SBP] >180 mm Hg)
- Within 1 month of a stroke or transient ischemic attack
- New York Heart Association (NYHA) heart failure class IV
- Patient has a serious or acute condition or illness that, in the judgment of theinvestigator, would interfere with evaluating the safety and/or efficacy assessmentsof the study (eg, a condition or illness requiring hemodialysis).
- Patient is pregnant or breast feeding.
- Patient has participated in another investigational study in the past 30 days.
- Patient is unable to understand the nature, scope, and possible consequences of theprotocol, or is unlikely or unable to comply with the protocol assessments, or isunlikely to complete the study for any reason.
- Patients who are not suitable for the study in the opinion of the investigator.
- Patient has experienced hypersensitivity to the active substance of theinvestigational product or to any of its excipients.
Study Design
Study Description
Connect with a study center
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia B3H 3A7
CanadaSite Not Available
Hotel Dieu Hospital
Kingston, Ontario K7L 5G2
CanadaSite Not Available
Kingston General Hospital
Kingston, Ontario K7L 2V7
CanadaSite Not Available
Hals - Nasen - Ohrenklinik und Poliklinik
Munich, 81675
GermanySite Not Available
Klinik für Hals-, Nasen- und Ohrenheilkunde
Ulm, 89075
GermanySite Not Available
Soroka University Medical Center
Beer Sheva, 84101
IsraelSite Not Available
Bnai Zion Medical Center
Haifa, 31048
IsraelSite Not Available
Ziv Medical Center
Safed, 13100
IsraelSite Not Available
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelSite Not Available
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE
United KingdomSite Not Available
Royal Devon and Exeter Hospital NHS Trust
Devon, EX2 5DW
United KingdomSite Not Available
Royal Devon and Exeter Hospital NHS Trust
Exeter, EX2 5DW
United KingdomSite Not Available
University Hospital Aintree
Liverpool, L9 7AL
United KingdomSite Not Available
University College London Hospitals (UCLH)
London, NW1 2BU
United KingdomSite Not Available
Manchester Royal Infirmary
Manchester, M13 9WL
United KingdomSite Not Available
Queen's Medical Centre
Nottingham, NG7 2UH
United KingdomSite Not Available
University of California San Diego
La Jolla, California 92093
United StatesSite Not Available
University of California San Diego Medical Center
La Jolla, California 92037
United StatesSite Not Available
University of California San Diego Medical Center
LaJolla, California 92037
United StatesSite Not Available
Kaiser Permanente Department of Allergy
San Francisco, California 94115
United StatesSite Not Available
Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Washington Hospital Center
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
UF Health Shands Hospital
Gainesville, Florida 32610
United StatesSite Not Available
Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
Tampa General Hospital
Tampa, Florida 33606
United StatesSite Not Available
Cook County Hospital
Chicago, Illinois 60612
United StatesSite Not Available
Federal Health Care Center
Chicago, Illinois 60064-3048
United StatesSite Not Available
Saint Francis Medical Center
Peoria, Illinois 61606
United StatesSite Not Available
University of Kansas Cancer Center
Kansas City, Kansas 66160
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Louisiana State University Health Science Center
New Orléans, Louisiana 70070
United StatesSite Not Available
University of Maryland School of Medicine
Baltimore, Maryland 21201
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Baystate Medical Center
Springfield, Massachusetts 01199
United StatesSite Not Available
Detroit Receiving Hospital and University Health Center
Detroit, Michigan 48201
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Sinai Grace Hospital
Detroit, Michigan 48201
United StatesSite Not Available
William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesSite Not Available
William Beaumont Hospital
Royal Oaks, Michigan 48073
United StatesSite Not Available
William Beaumont Hospital
Troy, Michigan 48085
United StatesSite Not Available
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216-4505
United StatesSite Not Available
Barnes Jewish Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63141
United StatesSite Not Available
Barnes Jewish Hospital
St. Louis, Missouri 63110
United StatesSite Not Available
Alegent Creighton Health Creighton University Medical Center
Omaha, Nebraska 68131
United StatesSite Not Available
Nevada Access To Research and Education Society
Las Vegas, Nevada 89106
United StatesSite Not Available
Inspira Health Network
Vineland, New Jersey 08360
United StatesSite Not Available
University of New Mexico
Albuquerque, New Mexico 87106
United StatesSite Not Available
Kings County Hospital Center
Brooklyn, New York 11203
United StatesSite Not Available
SUNY Downstate Medical Center
Brooklyn, New York 11203
United StatesSite Not Available
Weill Medical College of Cornell University
New York, New York 10021
United StatesSite Not Available
East Carolina University
Greenville, North Carolina 27835
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University Hospital - East
Gahanna, Ohio 43230
United StatesSite Not Available
Summit Health
Chambersburg, Pennsylvania 17201
United StatesSite Not Available
Albert Einstein Medical Center
Philadelphia, Pennsylvania 19141
United StatesSite Not Available
Hahnemann University Hospital
Philadelphia, Pennsylvania 19102
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Hahnemann University Hospital
Phildadelphia, Pennsylvania 19102
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15143
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
University of South Carolina School of Medicine
Columbia, South Carolina 29203
United StatesSite Not Available
Baylor University Medical Center
Dallas, Texas 75246
United StatesSite Not Available
John Peter Smith Hospital
Fort Worth, Texas 76104
United StatesSite Not Available
University of Texas Medical Branch
Galveston, Texas 77555-0561
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
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