BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
- Registration Number
- NCT00367770
- Lead Sponsor
- Actelion
- Brief 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.
- Detailed Description
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tracleer 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.
- Primary Outcome Measures
Name Time Method Change in 6-minute Walk Distance from baseline to week 24 Change in Borg Dyspnea Index from baseline to week 24 Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Number of Participants With a Change in WHO Functional Class from baseline to week 24 Number of participants with a change in WHO functional class from baseline to week 24.
A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Hospital Necker-Enfants Malades
🇫🇷Paris, France
Texas Children's Hospital
🇺🇸Houston, Texas, United States
BACH Pulmonary Hypertension Service
🇺🇸Boston, Massachusetts, United States
Royal Prince Alfred Hospital - Central Clinical School
🇦🇺Camperdown, Australia
The Peter Lougheed Centre
🇨🇦Calgary, Alberta, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Deutsches Herzzentrum Munchen
🇩🇪Munchen, Germany
Herzzentrum NRW
🇩🇪Bad Oeynhausen, Germany
University of Bologna
🇮🇹Bologna, Italy
San Matteo Hospital
🇮🇹Pavia, Italy
Unidad Medico Quirurgica de Cardiologia - Edificio General
🇪🇸Madrid, Spain
Scottish Vascular Unit - Western Infirmary
🇬🇧Glasgow, United Kingdom
Universitatsklinikum fur Innere Medizin II
🇦🇹Wien, Austria
UZ Gasthuisberg
🇧🇪Leuven, Belgium
The Royal Melbourne Hospital
🇦🇺Victoria, Australia
Royal Brompton Hospital
🇬🇧London, United Kingdom