Status:
COMPLETED
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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...
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 baselin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00367770
Start Date
January 1 2004
End Date
December 1 2005
Last Update
September 22 2016
Active Locations (17)
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1
BACH Pulmonary Hypertension Service
Boston, Massachusetts, United States, 02115
2
Texas Children's Hospital
Houston, Texas, United States, 77030-2303
3
Royal Prince Alfred Hospital - Central Clinical School
Camperdown, Australia, NSW 2050
4
The Royal Melbourne Hospital
Victoria, Australia, 3050