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

PHASE2TerminatedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

June 1, 2011

Primary Completion Date

June 1, 2012

Study Completion Date

June 1, 2012

Conditions
ACE Inhibitor Induced Angioedema
Interventions
DRUG

ecallantide 60 mg

Administered as two 3 mL SC injections, each containing 30 mg ecallantide

DRUG

ecallantide 30 mg

Administered as one 3 mL SC injection containing 30 mg ecallantide

DRUG

ecallantide 10 mg

Administered as one 3 mL SC injection containing 10 mg ecallantide.

DRUG

placebo

Administered as two SC 3 mL injections

DRUG

placebo match for 30 mg ecallantide arm

One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.

DRUG

placebo match for 10 mg ecallantide arm

One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.

Trial Locations (39)

10305

Staten Island University Hospital, Staten Island

11203

Kings County Hospital Center, Brooklyn

11501

Winthrop University Hospital, Mineola

15212

Allegheny General Hospital, Pittsburgh

19107

Thomas Jefferson University, Philadelphia

19141

Albert Einstein Medical Center, Philadelphia

19718

Christiana Hospital, Department of Emergency Medicine, Newark

20010

Washington Hospital Center, Washington D.C.

22908

University of Virginia Health System, Charlottesville

23507

Sentara Norfolk General Hospital, Norfolk

27157

Wake Forest Baptist Health, Winston-Salem

27834

East Carolina University, Greenville

29425

Medical University of South Carolina, Charleston

30033

DeKalb Medical, Decatur

30912

Georgia Health Sciences University, Augusta

33606

Tampa General Hospital, Tampa

36106

Er Med, Llc, Montgomery

43205

University Hospital East, Columbus

43210

The Ohio State University Medical Center, Columbus

44109

The MetroHealth System, Cleveland

48073

Beaumont Hospital, Royal Oak, Royal Oak

48085

Beaumont Hospital, Troy, Troy

48202

Henry Ford Hospital, Detroit

55415

Hennepin County Medical Center, Minneapolis

60612

University Consultants in Allergy and Immunology, Chicago

60616

Mercy Hospital and Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Medical Center, Kansas City

70121

Ochsner Clinic Foundation, New Orleans

75390

UT Southwestern Medical Center at Dallas, Dallas

76104

Emergency Medicine Residency Program, Fort Worth

77030

Baylor College of Medicine, Houston

77555

301 University Blvd., Galveston

77802

St Joseph Regional Health Center, Bryan

78701

University Medical Center Brackenridge, Austin

89106

Nevada Acess to Research and Education Study, Las Vegas

90095

University of California Los Angeles School of Medicine, Los Angeles

92103

University of California San Diego Mecial Center, San Diego

92324

Arrowhead Regional Medical Center, Colton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY