BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Pulmonary Arterial Hypertension
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring bosentan, PAH related to Eisenmenger physiology, Tracleer
Eligibility Criteria
Inclusion Criteria: Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study. For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those 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: Patients who withdrew prematurely from BREATHE-5, AC-052-405. Patients who are pregnant or nursing. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study. Patients with AST and/or ALT values greater than 3 times the upper limit of normal. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study). Patients with systolic blood pressure < 85 mm Hg. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product. Patients active on organ transplant list. Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus. Patients not able to comply with the protocol or adhere to therapy.
Sites / Locations
- BACH Pulmonary Hypertension Service
- Texas Children's Hospital
- Royal Prince Alfred Hospital - Central Clinical School
- The Royal Melbourne Hospital
- Universitatsklinikum fur Innere Medizin II
- UZ Gasthuisberg
- The Peter Lougheed Centre
- Toronto General Hospital
- Hospital Necker-Enfants Malades
- Herzzentrum NRW
- Deutsches Herzzentrum Munchen
- University of Bologna
- San Matteo Hospital
- Academisch Ziekenhuis Groningen
- Unidad Medico Quirurgica de Cardiologia - Edificio General
- Scottish Vascular Unit - Western Infirmary
- Royal Brompton Hospital
Arms of the Study
Arm 1
Experimental
Tracleer
The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.