Overview

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

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Actelion
Treatments:
Bosentan
Criteria
Inclusion Criteria:

1. Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind,
placebo- controlled 16-week study.

2. 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.

3. Patients providing written informed consent.

Exclusion Criteria:

1. Patients who withdrew prematurely from BREATHE-5, AC-052-405.

2. Patients who are pregnant or nursing.

3. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to
receive any of these drugs during the study.

4. Patients with AST and/or ALT values greater than 3 times the upper limit of normal.

5. Patients with hemoglobin or hematocrit that is more than 30% below the normal range
(patients with secondary polycythemia are permitted in the study).

6. Patients with systolic blood pressure < 85 mm Hg.

7. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or
are receiving another investigational product.

8. Patients active on organ transplant list.

9. Patients who are receiving or expected to receive glyburide, cyclosporin A or
tacrolimus.

10. Patients not able to comply with the protocol or adhere to therapy.