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

NCT00458276 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2018-07-09

No results posted yet for this study

Summary

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.

Conditions

  • Heart Diseases
  • Hypertension, 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.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Andre Denault, Prof. · Montreal Heart Institute

  • Ronald Pearl, MD · Stanford University

  • Robert Michler, MD · Montefiore Medical Center

  • Steven Tsui · Papworth Hospital NHS Foundation Trust

  • Rainald Seitelberger, Prof. · AKH University of Vienna

  • Andrea D'Armini, Prof. · San Matteo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-02-29
Completion
2008-03-31

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Poland
  • Serbia
  • Slovakia
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00458276 on ClinicalTrials.gov