Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension

January 31, 2025 updated by: Actelion

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

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.
157

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 3

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
      • Brisbane, Australia, 4032
        • The Prince Charles Hospital
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
      • Vienna, Austria, 1180
        • General Hospital of Vienna
  • Belgium
      • Brussels, Belgium, 1070
        • University Hospital Erasme
      • Leuven, Belgium, 3000
        • University Hospital Gathuisberg
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital Pulmonary & Critical Care Medicine
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • Centre de Pneumonologie de L'Hospital Laval
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • University of Western Ontario
  • Czech Republic
      • Praha 2, Czech Republic, 128 08
        • Charles University, Internal Medicine Department, (PAH unit)
  • France
      • Bron Cedex, France, 69677
        • Hopital Cardiologique Louis-Pradel
      • Clamart, France, 92140
        • Hopital Antoinw Beclere
  • Germany
      • Giessen, Germany, 35392
        • University Hospital Gießen
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Mainz, Germany, 55101
        • Johannes Gutenberg University Hospital
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S. Orsola-Malpighi
      • Orbassano, Italy, 10043
        • Azienda Ospedailera San Luigi
      • Pavia, Italy, 27100
        • San Matteo Hospital
      • Trieste, Italy, 34149
        • Ospedale di Cattinara
  • Netherlands
      • Amsterdam, Netherlands, 1100 DE
        • Academic Medical Center
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekennuis
  • Poland
      • Warszawa, Poland, 01-138
        • Medical University of Warsaw
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Clinico i Provincial
  • United Kingdom
      • Cambridge, United Kingdom, CB3 8RE
        • Papworth Hospital
      • Glasgow, United Kingdom, G11 5AA
        • Western Infirmary
  • United States
    • California
      • LaJolla, California, United States, 92037-1300
        • University of California at San Diego
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Division of Cardiovascular Diseases and Internal Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Medical Center

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic pulmonary hypertension in modified NYHA functional class II to IV due to CTEPH as demonstrated by ventilation/perfusion lung scanning and pulmonary angiography.
  • CTEPH judged inoperable because of peripheral localization of thrombotic material or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy (PEA) with no evidence of recurrent thromboembolism and not amenable to repeated surgery.
  • 6-minute walk test (6MWT) distance < 450 m.
  • Hemodynamic evaluation showing: Mean pulmonary arterial pressure (mPAP) >= 25 mmHg; Pulmonary capillary wedge pressure (PCWP) < 15 mmHg; Pulmonary vascular resistance (PVR) at rest >= 300 dyn×sec/cm5
  • For patients who underwent PEA, hemodynamic evaluation must have been performed more than 6 months after PEA.
  • For all patients, hemodynamic evaluation must have been performed with the 3 months immediately preceding inclusion.
  • Men or women >= 18 and =< 80 years of age (Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception).
  • Anticoagulants at efficacious dose for at least 3 months prior to randomization.
  • Signed informed consent prior to initiation of any study-mandated procedure.

Exclusion Criteria:

  • Other forms of pulmonary hypertension including pulmonary hypertension related to sickle cell disease.
  • Obstructive lung disease: FEV1/FVC < 0.5 after bronchodilator.
  • Severe restrictive lung disease: Total Lung Capacity < 60% of predicted value.
  • Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6MWT), e.g., angina pectoris, intermittent claudication.
  • Symptomatic pulmonary embolism within 6 months prior to randomization.
  • Pulmonary endarterectomy within 6 months prior to randomization.
  • Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
  • Illness with a life expectancy of less than 6 months.
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
  • AST and/or ALT > 3 times the upper limit of normal ranges.· Hemoglobin concentration < 75% the lower limit of normal ranges.
  • Pregnancy or breast-feeding.
  • Systolic blood pressure (BP) < 85 mmHg.
  • Treatment or planned treatment with another investigational drug and/or pulmonary angioplasty within 3 months prior to randomization.
  • Treatment with an endothelin receptor antagonist, a phosphodiesterase inhibitor, L-arginine or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 3 months prior to randomization.
  • Treatment for pulmonary hypertension within 1 month prior to randomization, excluding calcium channel blockers if present for at least 1 month before randomization.
  • Treatment with calcineurin-inhibitors (e.g., cyclosporine A and tacrolimus), sirolimus, fluconazole, glibenclamide (glyburide) within 1 week prior to randomization.
  • Known hypersensitivity to bosentan or any of the excipients.

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
Time Frame
Change from Baseline to Week 16 in 6-Minute Walk Test distance
Time Frame: Week 16
Week 16
Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest
Time Frame: Week 16
Week 16

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
Time Frame
Change from Baseline to Week 16 in modified NYHA functional class
Time Frame: Week 16
Week 16
Time to clinical worsening
Time Frame: Time to clinical worsening
Time to clinical worsening

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 1, 2005

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.
February 1, 2007

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.
March 1, 2007

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 10, 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 10, 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 12, 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-052-366

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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