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

Last updated: May 14, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Allergy

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT01919801
HGT-FIR-096
2014-001213-12
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, 18 years of age or older.
  2. Patient is currently being treated with an ACE inhibitor.
  3. 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).
  4. 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).
  5. 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.
  6. 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:

  1. 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).
  2. Patients with a family history of recurrent angioedema.
  3. Patients who have had a previous episode(s) of angioedema while not on ACE inhibitortherapy.
  4. Patients with acute urticaria (itchy, erythematous wheals).
  5. Patients who have an intervention to support the airway (eg, intubation, tracheotomy,cricothyrotomy) due to the current attack of angioedema.
  6. 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
  1. 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).
  2. Patient is pregnant or breast feeding.
  3. Patient has participated in another investigational study in the past 30 days.
  4. 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.
  5. Patients who are not suitable for the study in the opinion of the investigator.
  6. Patient has experienced hypersensitivity to the active substance of theinvestigational product or to any of its excipients.

Study Design

Total Participants: 118
Study Start date:
December 02, 2013
Estimated Completion Date:
August 22, 2015

Study Description

Angiotensin-converting enzyme inhibitors (ACE-Is) are the class of medications prescribed most frequently for the treatment of hypertension. They are also used post myocardial infarction as well as in patients with heart failure, diabetes mellitus, and chronic kidney disease. Approximately 35 to 40 million patients are on ACE-Is worldwide.

Study HGT-FIR-096 is a multicenter, Phase III, randomized, double-blind, two-armed, placebo-controlled trial. The study population will consist of 118 adult patients, 18 years of age or older, who present with an acute ACE-I-induced angioedema attack. The primary aim of the study is to demonstrate that icatibant is significantly more effective than placebo in resolving attacks of angioedema caused by ACE-I based on the Time to Meeting Discharge Criteria (TMDC). Safety and tolerability, as well as the pharmacokinetics (PK), of icatibant will also be evaluated. Eligible patients will be randomized at a 1:1 ratio to receive a single sub-cutaneous injection of either 30 mg icatibant or placebo.

Connect with a study center

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia B3H 3A7
    Canada

    Site Not Available

  • Hotel Dieu Hospital

    Kingston, Ontario K7L 5G2
    Canada

    Site Not Available

  • Kingston General Hospital

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Hals - Nasen - Ohrenklinik und Poliklinik

    Munich, 81675
    Germany

    Site Not Available

  • Klinik für Hals-, Nasen- und Ohrenheilkunde

    Ulm, 89075
    Germany

    Site Not Available

  • Soroka University Medical Center

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 31048
    Israel

    Site Not Available

  • Ziv Medical Center

    Safed, 13100
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 5BE
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital NHS Trust

    Devon, EX2 5DW
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital NHS Trust

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • University Hospital Aintree

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • University College London Hospitals (UCLH)

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Queen's Medical Centre

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • University of California San Diego Medical Center

    La Jolla, California 92037
    United States

    Site Not Available

  • University of California San Diego Medical Center

    LaJolla, California 92037
    United States

    Site Not Available

  • Kaiser Permanente Department of Allergy

    San Francisco, California 94115
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • UF Health Shands Hospital

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Orlando Health

    Orlando, Florida 32806
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Cook County Hospital

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Federal Health Care Center

    Chicago, Illinois 60064-3048
    United States

    Site Not Available

  • Saint Francis Medical Center

    Peoria, Illinois 61606
    United States

    Site Not Available

  • University of Kansas Cancer Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Louisiana State University Health Science Center

    New Orléans, Louisiana 70070
    United States

    Site Not Available

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • Detroit Receiving Hospital and University Health Center

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Sinai Grace Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oaks, Michigan 48073
    United States

    Site Not Available

  • William Beaumont Hospital

    Troy, Michigan 48085
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Barnes Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Barnes Jewish Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Alegent Creighton Health Creighton University Medical Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Nevada Access To Research and Education Society

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Inspira Health Network

    Vineland, New Jersey 08360
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Kings County Hospital Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Weill Medical College of Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27835
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University Hospital - East

    Gahanna, Ohio 43230
    United States

    Site Not Available

  • Summit Health

    Chambersburg, Pennsylvania 17201
    United States

    Site Not Available

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Hahnemann University Hospital

    Phildadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15143
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • University of South Carolina School of Medicine

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • John Peter Smith Hospital

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-0561
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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