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Clinical trialNCT00458276TerminatedPhase 3Interventional

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

SponsorIdorsia Pharmaceuticals Ltd.Enrollment274Heart DiseasesHypertension, Pulmonary
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

33 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria
  • Medical University of Innsbruck

    Innsbruck, Austria

  • Akh University of Vienna

    Vienna, Austria

Canada
  • University of Alberta Hospital

    Edmonton, Alberta, Canada

  • London Health Sciences Centre-University Hospital

    London, Ontario, Canada

  • Toronto General Hospital

    Toronto, Ontario, Canada

  • Montreal Heart Institute

    Montreal, Quebec, Canada

  • Quebec Heart Institute/hopital Laval

    Québec, Quebec, Canada

Czechia
  • Institute for Clinical and Experimental Medicine (ikem)

    Prague, Czechia

France
  • Hopital Pitie Salpetriere

    Paris, France

Germany
  • Deutches Herzzentrum

    Berlin, Germany

  • Dresden Universitatsklinik/cardiology Center

    Dresden, Germany

  • Zentrum Der Chirugie-Zchir-Des Universitatsklinikums

    Frankfurt, Germany

India
  • Narayana Hrudayalaya

    Bangalore, India

  • Nizam'S Institute of Medical Sciences

    Hyderabaad, India

Israel
  • Shaare Zedek Medical Center

    Jerusalem, Israel

Italy
  • Fondazione Irccs San Matteo Hospital, Cardiac Surgery

    Pavia, Italy

  • Azienda Sanitaria Ospedaliera "san Giovanni Battista", Cardiac Surgery Division

    Torino, Italy

Poland
  • Medical University of Silesia, 2nd Dept of Cardiac Surgery

    Katowice, Poland

  • Klinika Chirurgii Serca, Naczyn I Transplantologii, Szpital Jana Pawla Ii

    Krakow, Poland

Serbia
  • Dedinje Cardiovascular Institute

    Belgrade, Serbia

Slovakia
  • National Institute of Cardiovascular Diseases, Clinic of Heart Surgery

    Bratislava, Slovakia

Sweden
  • Sahlgrenska University Hospital

    Gothenburg, Sweden

United Kingdom
  • Papworth Hospital

    Cambridge, United Kingdom

  • Northern General Hospital

    Sheffield, United Kingdom

United States
  • Stanford University School of Medicine

    Stanford, California, United States

  • Columbia University Medical Center

    New York, New York, United States

  • Montefiore Medical Center/albert Einstein College of Medicine

    New York, New York, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, United States

  • the Cleveland Clinic

    Cleveland, Ohio, United States

  • Baylor University Medical Center

    Dallas, Texas, United States

  • Texas Heart Institute/st. Luke'S Episcopal Hospital/baylor College

    Houston, Texas, United States

  • University of Virginia Health System

    Charlottesville, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboTEZOSENTAN
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2007
Primary completion
29 Feb 2008
Completion
31 Mar 2008
Last update posted
9 Jul 2018
Registered enrollment
274
Registry id
NCT00458276

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.