Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Completed · Phase 3 · Has a placebo group

Conditions studied: Angiotensin Converting Enzyme Inhibitor Induced Angioedema

In brief

This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.

Key facts

Study ID: NCT01919801
Run by: Shire
People needed: 118
Starts: 2013-12-02
Expected to finish: 2015-08-22
Last updated by the study team: 2021-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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/or neck region within 12 hours of onset (must be sufficiently less than 12 hours to allow study drug to be given with 12 hours of attack onset).
Angioedema must be considered at least moderate in severity for at least one of the four angioedema-associated airway symptoms (difficulty breathing, difficulty swallowing, voice changes, tongue swelling).
Patient must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.
Females must have a negative urine pregnancy test prior to administration of the study medication, with the exception of those females who have had a total hysterectomy or bilateral oophorectomy, or who are 2 years post-menopausal.

You may not qualify if…

Patient has a diagnosis of angioedema of other etiology (eg, hereditary or acquired angioedema, allergic angioedema [eg, food, insect bite or sting, evident clinical response to antihistamines and/or corticosteroids], anaphylaxis, trauma, abscess or infection or associated disease, local inflammation, local tumor, post-operative or post-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 inhibitor therapy.
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 the investigator, 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 or systolic 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 the investigator, would interfere with evaluating the safety and/or efficacy assessments of 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 the protocol, or is unlikely or unable to comply with the protocol assessments, or is unlikely 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 the investigational product or to any of its excipients.

Where it is running

University of California San Diego — La Jolla, California, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
UF Health Shands Hospital — Gainesville, Florida, United States
Orlando Health — Orlando, Florida, United States
Tampa General Hospital — Tampa, Florida, United States
Federal Health Care Center — Chicago, Illinois, United States
Cook County Hospital — Chicago, Illinois, United States
University of Kansas Cancer Center — Kansas City, Kansas, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
University of Maryland School of Medicine — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Brigham and Womens Hospital — Boston, Massachusetts, United States
Baystate Medical Center — Springfield, Massachusetts, United States
Detroit Receiving Hospital and University Health Center — Detroit, Michigan, United States
Sinai Grace Hospital — Detroit, Michigan, United States
Henry Ford Health System — Detroit, Michigan, United States
William Beaumont Hospital — Royal Oak, Michigan, United States
William Beaumont Hospital — Troy, Michigan, United States
Hennepin County Medical Center — Minneapolis, Minnesota, United States
Barnes Jewish Hospital — St Louis, Missouri, United States
Washington University — St Louis, Missouri, United States
Inspira Health Network — Vineland, New Jersey, United States
University of New Mexico — Albuquerque, New Mexico, United States
Kings County Hospital Center — Brooklyn, New York, United States
University of California San Diego Medical Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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