BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Completed · Phase 4

Conditions studied: Pulmonary Arterial Hypertension

In brief

This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

Key facts

Study ID

NCT00367770

Run by

Actelion

People needed

37

Starts

2004-01-01

Expected to finish

2005-12-01

Last updated by the study team

2016-09-22

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• BACH Pulmonary Hypertension Service — Boston, Massachusetts, United States
• Texas Children's Hospital — Houston, Texas, United States
• Royal Prince Alfred Hospital - Central Clinical School — Camperdown, Australia
• The Royal Melbourne Hospital — Victoria, Australia
• Universitatsklinikum fur Innere Medizin II — Vienna, Austria
• UZ Gasthuisberg — Leuven, Belgium
• The Peter Lougheed Centre — Calgary, Alberta, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Hospital Necker-Enfants Malades — Paris, France
• Herzzentrum NRW — Bad Oeynhausen, Germany
• Deutsches Herzzentrum Munchen — München, Germany
• University of Bologna — Bologna, Italy
• San Matteo Hospital — Pavia, Italy
• Academisch Ziekenhuis Groningen — Groningen, Netherlands
• Unidad Medico Quirurgica de Cardiologia - Edificio General — Madrid, Spain
• Scottish Vascular Unit - Western Infirmary — Glasgow, United Kingdom
• Royal Brompton Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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