Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

January 31, 2025 updated by: Actelion

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology. Patients receive bosentan or placebo for 16 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia, NSW 2050
        • Royal Prince Alfred Hospital - Central Clinical School
      • Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Austria
      • Wien, Austria, AT-1090
        • Universitatsklinikum fur Innere Medizin II
  • Belgium
      • Leuven, Belgium, BE-3000
        • UZ Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • The Peter Lougheed Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • France
      • Paris, France, 75007
        • Hospital Necker-Enfants Malades
  • Germany
      • Bad Oeynhausen, Germany, D-32545
        • Herzzentrum NRW
      • Munchen, Germany, D-80636
        • Deutsches Herzzentrum München
  • Italy
      • Bologna, Italy, 40138
        • University of Bologna
      • Pavia, Italy, 27100
        • San Matteo Hospital
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Academisch Ziekenhuis Groningen
  • Spain
      • Madrid, Spain, 28046
        • Unidad Medico Quirurgica de Cardiologia - Edificio General
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Scottish Vascular Unit - Western Infirmary
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • BACH Pulmonary Hypertension Service
    • Texas
      • Houston, Texas, United States, 77030-2303
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients at least 12 years with a body weight at least 40 kg (inclusive) and with a functional class III (1998 WHO classification).
  2. Patients with pulmonary arterial hypertension related to Eisenmenger physiology echocardiographically established as atrial septal defect at least 2 cm effective diameter and/or ventricular septal defect at least 1 cm effective diameter; PAH confirmed via cardiac catheterization: mean pulmonary arterial pressure >25 mm Hg, pulmonary capillary wedge pressure <15 mm Hg and pulmonary vascular resistance >3 mm Hg/l/min.
  3. Patients with documented oxygen saturation up to 90%, and >70% (at rest, with room air).
  4. Patients able to perform a 6-minute walk test at least 150 m, and up to 450 m.
  5. Patients stable for at least 3 months prior to screening.
  6. Bosentan naïve patients.
  7. Female patients who are surgically sterile, postmenopausal or have documented infertility.
  8. Female patients of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended; intrauterine devices (IUDs); oral or implanted contraceptives, if used in combination with a barrier method.
  9. Patients providing written informed consent.

Exclusion Criteria:

  1. Pregnant patients, nursing mothers.
  2. Patients with left ventricular dysfunction (ejection fraction <40%).
  3. Patients with restrictive lung disease (TLC<70% predicted); obstructive lung disease (FEV1<70% predicted, with FEV1/FVC<60%)
  4. Patients with systolic blood pressure < 85 mm Hg.
  5. Patients with other conditions that may affect the ability to perform a 6-minute walk test.
  6. Patients unable to provide informed consent and comply with the patient protocol.
  7. Patients with known coronary arterial disease.
  8. Patients with serum creatinine >125 µM/l.
  9. Patients with iron deficiency (serum ferritin <10 ng/ml) unless corrected by iron supplement.
  10. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted).
  11. Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
  12. Patients who have started or stopped treatment for PAH within one month of screening, excluding anticoagulation.
  13. Patients who are receiving glyburide (glibenclamide), cyclosporine A or tacrolimus at inclusion or are expected to receive any of these drugs during the study.
  14. Patients who are receiving vasodilators including, but not limited to epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
  15. Patients active on organ transplant lists.
  16. Patients taking phosphodiesterase inhibitors or endothelin receptor antagonists (other than bosentan) or any other investigational drugs/devices.
  17. Patients with planned surgical intervention during the study period.

  18. Cardiac catheterization-specific exclusion criteria:

    1. Patients who cannot safely have catheterization performed as indicated.
    2. Patients in whom shunting is not at the atrial or ventricular level.
    3. Patients with nonequal pulmonary venous desaturation that theoretically cannot be corrected with administration of 100% non-rebreather-supplied oxygen.
    4. Patients with nonpulsatile pulmonary blood flow, or with multiple sources of pulmonary blood flow.
    5. Patients with discontinuous pulmonary arteries, peripheral pulmonary arterial or venous stenosis > 25% size of native PA or creating unequal bilateral PA mean pressures, PA band with gradient > 20 mm Hg, tetralogy of fallot/pulmonary atresia, VSD/pulmonary atresia, DORV/pulmonary atresia, truncus arteriosus, scimitar syndrome.
    6. Patients where SVC sampling cannot be performed, or where SVC sampling may be contaminated
    7. Patients with ductus arteriosus.
    8. Patients with mitral or pulmonary venous stenosis, intracavitary LV outflow obstruction, sub, valvar or supravalvar aortic stenosis or aortic coarctation.
    9. Patients with <10 indexed Wood units, greater than moderate mitral regurgitation, mean pulmonary venous pressure > 16 mm Hg, pulmonary venous "v" waves > 20 mm Hg, systemic ventricular end-diastolic pressure > 16 mm Hg; patients with recognized extracardiac systemic venous collaterals to the pulmonary venous circulation, patients with recognized hepatic wedge pressure-inferior vena cava pressure gradient > 12 mm Hg.
    10. Patients (during catheterization) with uncorrectable hypercarbia with pCO2 >55 mm Hg; patients with uncorrectable acidemia with pH <7.34; patients in active pain or distress; unconscious or mechanically ventilated patients; patients with unstable systemic or pulmonary blood flow; systemic arterial or pulmonary artery pressures or hematocrit (change of > 25% during catheterization); unstable cardiac rhythm dissimilar to baseline cardiac rhythm during physical examination assessments for the entire duration of the catheterization excepting nonsustained arrhythmia; patients with documented or recognized air embolism, hemorrhage, cardiac, cerebral or peripheral organ ischemia occurring during or immediately preceding the catheterization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Change from baseline to Week 16 in oxygen saturation at rest with room air
Change from baseline to Week 16 in indexed pulmonary vascular resistance

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Changes from baseline to Week 16 in cardiac hemodynamics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2006

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-052-405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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