- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317486
Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
February 11, 2010 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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- 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
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Camperdown, Australia, NSW 2050
- Royal Prince Alfred Hospital - Central Clinical School
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Victoria, Australia, 3050
- The Royal Melbourne Hospital
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Wien, Austria, AT-1090
- Universitatsklinikum fur Innere Medizin II
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Leuven, Belgium, BE-3000
- UZ Gasthuisberg
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Alberta
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Calgary, Alberta, Canada, T1Y 6J4
- The Peter Lougheed Centre
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Paris, France, 75007
- Hospital Necker-Enfants Malades
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Bad Oeynhausen, Germany, D-32545
- Herzzentrum NRW
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Munchen, Germany, D-80636
- Deutsches Herzzentrum München
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Bologna, Italy, 40138
- University of Bologna
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Pavia, Italy, 27100
- San Matteo Hospital
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Groningen, Netherlands, 9713 GZ
- Academisch Ziekenhuis Groningen
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Madrid, Spain, 28046
- Unidad Medico Quirurgica de Cardiologia - Edificio General
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Glasgow, United Kingdom, G11 6NT
- Scottish Vascular Unit - Western Infirmary
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London, United Kingdom, SW3 6NP
- Royal Brompton Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02115
- BACH Pulmonary Hypertension Service
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Texas
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Houston, Texas, United States, 77030-2303
- Texas Children's Hospital
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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
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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.
- Patients with documented oxygen saturation up to 90%, and >70% (at rest, with room air).
- Patients able to perform a 6-minute walk test at least 150 m, and up to 450 m.
- Patients stable for at least 3 months prior to screening.
- Bosentan naïve patients.
- Female patients who are surgically sterile, postmenopausal or have documented infertility.
- 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.
- Patients providing written informed consent.
Exclusion Criteria:
- Pregnant patients, nursing mothers.
- Patients with left ventricular dysfunction (ejection fraction <40%).
- Patients with restrictive lung disease (TLC<70% predicted); obstructive lung disease (FEV1<70% predicted, with FEV1/FVC<60%)
- Patients with systolic blood pressure < 85 mm Hg.
- Patients with other conditions that may affect the ability to perform a 6-minute walk test.
- Patients unable to provide informed consent and comply with the patient protocol.
- Patients with known coronary arterial disease.
- Patients with serum creatinine >125 µM/l.
- Patients with iron deficiency (serum ferritin <10 ng/ml) unless corrected by iron supplement.
- Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted).
- Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
- Patients who have started or stopped treatment for PAH within one month of screening, excluding anticoagulation.
- Patients who are receiving glyburide (glibenclamide), cyclosporine A or tacrolimus at inclusion or are expected to receive any of these drugs during the study.
- 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.
- Patients active on organ transplant lists.
- Patients taking phosphodiesterase inhibitors or endothelin receptor antagonists (other than bosentan) or any other investigational drugs/devices.
- Patients with planned surgical intervention during the study period.
Cardiac catheterization-specific exclusion criteria:
- Patients who cannot safely have catheterization performed as indicated.
- Patients in whom shunting is not at the atrial or ventricular level.
- Patients with nonequal pulmonary venous desaturation that theoretically cannot be corrected with administration of 100% non-rebreather-supplied oxygen.
- Patients with nonpulsatile pulmonary blood flow, or with multiple sources of pulmonary blood flow.
- 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.
- Patients where SVC sampling cannot be performed, or where SVC sampling may be contaminated
- Patients with ductus arteriosus.
- Patients with mitral or pulmonary venous stenosis, intracavitary LV outflow obstruction, sub, valvar or supravalvar aortic stenosis or aortic coarctation.
- 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.
- 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
Outcome Measure |
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Change from baseline to Week 16 in oxygen saturation at rest with room air
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Change from baseline to Week 16 in indexed pulmonary vascular resistance
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Secondary Outcome Measures
Outcome Measure |
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Changes from baseline to Week 16 in cardiac hemodynamics
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2003
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
April 21, 2006
First Submitted That Met QC Criteria
April 21, 2006
First Posted (Estimate)
April 25, 2006
Study Record Updates
Last Update Posted (Estimate)
February 15, 2010
Last Update Submitted That Met QC Criteria
February 11, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Congenital Abnormalities
- Hypertension, Pulmonary
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Hypertension
- Pulmonary Arterial Hypertension
- Familial Primary Pulmonary Hypertension
- Eisenmenger Complex
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Endothelin Receptor Antagonists
- Bosentan
Other Study ID 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.
Clinical Trials on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
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ActelionCompletedPulmonary Arterial HypertensionCanada, United Kingdom, Italy, United States, Netherlands, Australia, Austria, Belgium, France, Germany, Spain
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Competence Network for Congenital Heart DefectsGerman Federal Ministry of Education and ResearchTerminatedTherapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger PatientsPulmonary Arterial Hypertension (PAH)Germany
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ActelionCanadian Heart Research CentreCompletedPulmonary Arterial HypertensionUnited States
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ActelionTerminatedPulmonary Arterial HypertensionChina, Malaysia, United States, Austria, Bulgaria, Chile, France, Germany, Greece, Mexico, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, United Kingdom, Vietnam
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ActelionCompletedPulmonary Arterial HypertensionChina, Malaysia, United States, Austria, Bulgaria, Chile, France, Germany, Greece, Israel, Mexico, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Turkey, United Kingdom, Vietnam
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Masih Daneshvari HospitalUnknownIdiopathic Pulmonary Arterial Hypertension | Eisenmenger SyndromeIran, Islamic Republic of
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Heidelberg UniversityRecruitingPulmonary Arterial Hypertension | Eisenmenger SyndromeGermany
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Competence Network for Congenital Heart DefectsGerman Federal Ministry of Education and Research; ActelionCompleted
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University of California, Los AngelesActelionTerminatedPulmonary Arterial Hypertension | Congenital Heart Disease | Eisenmenger's SyndromeUnited States
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Federal University of São PauloUnknownPulmonary Hypertension | Congenital Heart Defects | Eisenmenger ComplexBrazil
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