Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema



Status:Terminated
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:June 1, 2011
End Date:June 1, 2012

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Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

A double-blind, randomized, controlled trial comparing the safety and effectiveness of
conventional therapy with ecallantide to conventional therapy with placebo.


Inclusion Criteria:

- Males and females 18 years of age or older

- Must currently be on ACE inhibitor therapy and have received a dose within 36 hours

- Presenting with ACEIA of the head/neck region within 12 hours after onset

- All females must have a negative urine pregnancy test prior to administration of the
study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two
years post-menopausal do not require a pregnancy test.

Exclusion Criteria:

- Hypersensitivity to ecallantide

- Pregnancy or breast feeding

- Patients who have had angioedema and were not concurrently on an ACE inhibitor

- Patients exhibiting urticaria

- Patients who are intubated or who have a tracheostomy related to the current episode
of angioedema

- Opinion of the investigator that the patient would not be a good candidate

- Participation in another investigational study within 30 days prior to enrollment
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New Orleans, Louisiana 70121
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1200 Moursund Street
Houston, Texas 77030
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1 Tampa General Cir
Tampa, Florida 33606
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1459 Laney-Walker Blvd
Augusta, Georgia 30901
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Georgia Health Sciences University Georgia Regents University, home of the Medical College of Georgia, is...
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Austin, TX
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Brooklyn, New York 11203
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497
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Bryan, TX
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Chicago, IL
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Chicago, Illinois 60616
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Cleveland, Ohio 44109
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Colton, California 92324
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Columbus, Ohio 43205
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349
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Decatur, Georgia
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Fort Worth, Texas 76104
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Galveston, Texas 77555
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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259 1st St
Mineola, New York 11501
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Minneapolis, Minnesota 55414
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Montgomery, Alabama 36106
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
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Royal Oak, Michigan 48314
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660 S Euclid Ave
Saint Louis, Missouri 63110
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475 Seaview Ave
Staten Island, New York 10305
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44201 Dequindre Road
Troy, Michigan 48085
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Winston-Salem, North Carolina 27157
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