Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery

PHASE3TerminatedINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

February 29, 2008

Study Completion Date

March 31, 2008

Conditions
Heart DiseasesHypertension, Pulmonary
Interventions
DRUG

tezosentan

Tezosentan (ACT-050089, Ro 61-0612) as a 1% solution in 0.9% NaCl (i.e., normal saline) for i.v. use.

DRUG

placebo

Placebo (i.e., normal saline) for i.v. use.

Trial Locations (33)

10032

Columbia University Medical Center, New York

10126

"Azienda Sanitaria Ospedaliera San Giovanni Battista, Cardiac Surgery Division", Torino

10467

Montefiore Medical Center/Albert Einstein College of Medicine, New York

22908

University of Virginia Health System, Charlottesville

27100

Fondazione IRCCS San Matteo Hospital, Cardiac Surgery, Pavia

27157

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Medical Center, Durham

44195

The Cleveland Clinic, Cleveland

75226

Baylor University Medical Center, Dallas

77030

Texas Heart Institute/St. Luke's Episcopal Hospital/Baylor College, Houston

94305

Stanford University School of Medicine, Stanford

Unknown

Medical University of Innsbruck, Innsbruck

AKH University of Vienna, Vienna

Institute for Clinical and Experimental Medicine (IKEM), Prague

Hopital Pitie Salpetriere, Paris

Deutches Herzzentrum, Berlin

Dresden Universitatsklinik/Cardiology Center, Dresden

Narayana Hrudayalaya, Bangalore

Nizam's Institute of Medical Sciences, Hyderabaad

Shaare Zedek Medical Center, Jerusalem

Medical University of Silesia, 2nd Dept of Cardiac Surgery, Katowice

Dedinje Cardiovascular Institute, Belgrade

National Institute of Cardiovascular Diseases, Clinic of Heart Surgery, Bratislava

Sahlgrenska University Hospital, Gothenburg

Papworth Hospital, Cambridge

Northern General Hospital, Sheffield

T6G2B7

University of Alberta Hospital, Edmonton

N6A5A5

London Health Sciences Centre-University Hospital, London

M5G2C4

Toronto General Hospital, Toronto

H1T1C8

Montreal Heart Institute, Montreal

G1V4G5

Quebec Heart Institute/Hopital Laval, Québec

Main 60590

Zentrum der Chirugie-Zchir-des Universitatsklinikums, Frankfurt

31-202

Klinika Chirurgii Serca, Naczyn I Transplantologii, Szpital Jana Pawla II, Krakow

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY

NCT00458276 - Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery | Biotech Hunter | Biotech Hunter