NCT01574248

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 17, 2017

Completed
Last Updated

February 17, 2017

Status Verified

December 1, 2016

Enrollment Period

4.1 years

First QC Date

December 14, 2011

Results QC Date

October 28, 2016

Last Update Submit

December 22, 2016

Conditions

ACE Inhibitor-associated Angioedema

Keywords

ACE inhibitorAngioedemaBradykininSwelling

Outcome Measures

Primary Outcomes (1)

  • Time to Resolution of Angioedema

    Time interval between initiation of treatment and when there is no symptom, by visual analog scale \<1 cm. Data provided are for worst symptom.

    48 hours

Secondary Outcomes (6)

  • Number of Participants With Admission to Intensive Care Unit

    T0 to T48 hours

  • Number of Participants With Requirement for Intubation

    T0 to T48 hours

  • Number of Participants Given Steroids

    T0 to T48 hours

  • Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers

    T0 to T48 hours

  • Number of Participants Given Epinephrine

    T0 to T48 hours

  • +1 more secondary outcomes

Study Arms (2)

icatibant

EXPERIMENTAL

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

Drug: icatibant

Placebo

PLACEBO COMPARATOR

Subcutaneous at time 0 and 6 hours

Other: Placebo

Interventions

icatibantDRUG

Subcutaneous at time 0 and 6 hours

Also known as: Firazyr, HOE140
icatibant
PlaceboOTHER

Subcutaneous at time 0 and 6 hours

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has ongoing angioedema while taking an ACE inhibitor.
  • The subject is between 18 and 80 years of age.

You may not qualify if:

  • The subject has had angioedema while not taking an ACE inhibitor.
  • The subject's angioedema only involves the bowel.
  • The subject is known to be pregnant or has a positive urine pregnancy test.
  • The subject has started on an oral contraceptive within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Diego

San Diego, California, 92093, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Location

Related Publications (9)

  • Byrd JB, Adam A, Brown NJ. Angiotensin-converting enzyme inhibitor-associated angioedema. Immunol Allergy Clin North Am. 2006 Nov;26(4):725-37. doi: 10.1016/j.iac.2006.08.001.

    PMID: 17085287BACKGROUND

  • Brown NJ, Ray WA, Snowden M, Griffin MR. Black Americans have an increased rate of angiotensin converting enzyme inhibitor-associated angioedema. Clin Pharmacol Ther. 1996 Jul;60(1):8-13. doi: 10.1016/S0009-9236(96)90161-7.

    PMID: 8689816BACKGROUND

  • Brown NJ, Byiers S, Carr D, Maldonado M, Warner BA. Dipeptidyl peptidase-IV inhibitor use associated with increased risk of ACE inhibitor-associated angioedema. Hypertension. 2009 Sep;54(3):516-23. doi: 10.1161/HYPERTENSIONAHA.109.134197. Epub 2009 Jul 6.

    PMID: 19581505BACKGROUND

  • Gainer JV, Morrow JD, Loveland A, King DJ, Brown NJ. Effect of bradykinin-receptor blockade on the response to angiotensin-converting-enzyme inhibitor in normotensive and hypertensive subjects. N Engl J Med. 1998 Oct 29;339(18):1285-92. doi: 10.1056/NEJM199810293391804.

    PMID: 9791144BACKGROUND

  • Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med. 2008 Sep 4;359(10):1027-36. doi: 10.1056/NEJMcp0803977. No abstract available.

    PMID: 18768946BACKGROUND

  • Verresen L, Fink E, Lemke HD, Vanrenterghem Y. Bradykinin is a mediator of anaphylactoid reactions during hemodialysis with AN69 membranes. Kidney Int. 1994 May;45(5):1497-503. doi: 10.1038/ki.1994.195.

    PMID: 8072263BACKGROUND

  • Krieter DH, Grude M, Lemke HD, Fink E, Bonner G, Scholkens BA, Schulz E, Muller GA. Anaphylactoid reactions during hemodialysis in sheep are ACE inhibitor dose-dependent and mediated by bradykinin. Kidney Int. 1998 Apr;53(4):1026-35. doi: 10.1111/j.1523-1755.1998.00837.x.

    PMID: 9551414BACKGROUND

  • Bork K, Frank J, Grundt B, Schlattmann P, Nussberger J, Kreuz W. Treatment of acute edema attacks in hereditary angioedema with a bradykinin receptor-2 antagonist (Icatibant). J Allergy Clin Immunol. 2007 Jun;119(6):1497-503. doi: 10.1016/j.jaci.2007.02.012. Epub 2007 Apr 5.

    PMID: 17418383BACKGROUND

  • Brown NJ, Snowden M, Griffin MR. Recurrent angiotensin-converting enzyme inhibitor--associated angioedema. JAMA. 1997 Jul 16;278(3):232-3. doi: 10.1001/jama.278.3.232.

    PMID: 9218671BACKGROUND

MeSH Terms

Conditions

Angioedema

Interventions

icatibant

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Nancy J. Brown, M.D.
Organization
Vanderbilt University Medical Center
nancy.j.brown@vanderbilt.edu
6153438701

Study Officials

  • Nancy J. Brown, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
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
Chair Department of Medicine

Study Record Dates

First Submitted

December 14, 2011

First Posted

April 10, 2012

Study Start

August 1, 2011

Primary Completion

September 1, 2015

Study Completion

February 1, 2016

Last Updated

February 17, 2017

Results First Posted

February 17, 2017

Record last verified: 2016-12

Locations

US(2)