Phase 4
Completed N=37
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Source: ClinicalTrials.gov NCT00367770 ↗Enrolled (actual)
37
Serious AEs
18.9%
Results posted
Aug 2016
Primary outcomePrimary: Change in 6-minute Walk Distance — 13.5 m
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 6-minute Walk Distance |
13.5 | — |
| PRIMARY Change in Borg Dyspnea Index |
0.1 | — |
| PRIMARY Number of Participants With a Change in WHO Functional Class |
13 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00367770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.