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

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: Tracleer® (bosentan) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Actelion

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.

Official title: A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Serious adverse events

Adverse events leading to dose reduction, temporary interruption or permanent discontinuation

Laboratory tests and oxygen saturation

Secondary outcome:

Six minute walk test at week 24

Borg dyspnea index at week 24

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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 amenrrheic 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

The Royal Melbourne Hospital, Victoria 3050, Australia

Royal Prince Alfred Hospital - Central Clinical School, Camperdown NSW 2050, Australia

Universitatsklinikum fur Innere Medizin II, Wien AT-1090, Austria

UZ Gasthuisberg, Leuven BE-3000, Belgium

Hospital Necker-Enfants Malades, Paris 75007, France

Herzzentrum NRW, Bad Oeynhausen D-32545, Germany

Deutsches Herzzentrum Munchen, Munchen D-80636, Germany

University of Bologna, Bologna 40138, Italy

San Matteo Hospital, Pavia 27100, Italy

Academisch Ziekenhuis Groningen, Groningen 9713 GZ, Netherlands

Unidad Medico Quirurgica de Cardiologia - Edificio General, Madrid 28046, Spain

Scottish Vascular Unit - Western Infirmary, Glasgow G11 6NT, United Kingdom

Royal Brompton Hospital, London SW3 6NP, United Kingdom

The Peter Lougheed Centre, Calgary, Alberta T1Y 6J4, Canada

BACH Pulmonary Hypertension Service, Boston, Massachusetts 02115, United States

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada

Texas Children's Hospital, Houston, Texas 77030-2303, United States

Starting date: January 2004
Ending date: December 2005
Last updated: November 14, 2006