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

PHASE3CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

December 2, 2013

Primary Completion Date

August 22, 2015

Study Completion Date

August 22, 2015

Conditions
Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Interventions
DRUG

Icatibant

Single dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema

DRUG

Placebo

Trial Locations (55)

10021

Weill Medical College of Cornell University, New York

11203

Kings County Hospital Center, Brooklyn

SUNY Downstate Medical Center, Brooklyn

13100

Ziv Medical Center, Safed

15143

Allegheny General Hospital, Pittsburgh

17201

Summit Health, Chambersburg

19102

Hahnemann University Hospital, Philadelphia

19140

Temple University Hospital, Philadelphia

19141

Albert Einstein Medical Center, Philadelphia

20010

Washington Hospital Center, Washington D.C.

21201

University of Maryland School of Medicine, Baltimore

22903

University of Virginia, Charlottesville

27835

East Carolina University, Greenville

29203

University of South Carolina School of Medicine, Columbia

31048

Bnai Zion Medical Center, Haifa

32610

UF Health Shands Hospital, Gainesville

32806

Orlando Health, Orlando

33606

Tampa General Hospital, Tampa

43230

Ohio State University Hospital - East, Gahanna

44195

Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati, Cincinnati

48073

William Beaumont Hospital, Royal Oak

48085

William Beaumont Hospital, Troy

48201

Detroit Receiving Hospital and University Health Center, Detroit

Sinai Grace Hospital, Detroit

48202

Henry Ford Health System, Detroit

55415

Hennepin County Medical Center, Minneapolis

60612

Cook County Hospital, Chicago

63110

Barnes Jewish Hospital, St Louis

63141

Washington University, St Louis

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

66160

University of Kansas Cancer Center, Kansas City

70121

Ochsner Medical Center, New Orleans

75246

Baylor University Medical Center, Dallas

76104

John Peter Smith Hospital, Fort Worth

77030

Baylor College of Medicine, Houston

84101

Soroka University Medical Center, Beersheba

87106

University of New Mexico, Albuquerque

92037

University of California San Diego Medical Center, La Jolla

92093

University of California San Diego, La Jolla

60064-3048

Federal Health Care Center, Chicago

02114

Massachusetts General Hospital, Boston

02115

Brigham and Womens Hospital, Boston

01199

Baystate Medical Center, Springfield

08360

Inspira Health Network, Vineland

02903

Rhode Island Hospital, Providence

77555-0561

University of Texas Medical Branch, Galveston

B3H 3A7

Queen Elizabeth II Health Sciences Center, Halifax

K7L 2V7

Kingston General Hospital, Kingston

K7L 5G2

Hotel Dieu Hospital, Kingston

BN2 5BE

Brighton and Sussex University Hospitals NHS Trust, Brighton

EX2 5DW

Royal Devon and Exeter Hospital NHS Trust, Exeter

L9 7AL

University Hospital Aintree, Liverpool

M13 9WL

Manchester Royal Infirmary, Manchester

NG7 2UH

Queen's Medical Centre, Nottingham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Shire

INDUSTRY

NCT01919801 - Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema | Biotech Hunter | Biotech Hunter