CompletedPhase 4

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

United States, Australia, Austria37 participantsStarted 2004-01

Plain-language 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.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in 6-minute Walk Distance

Timeframe: from baseline to week 24

Change in Borg Dyspnea Index

Timeframe: from baseline to week 24

Number of Participants With a Change in WHO Functional Class

Timeframe: from baseline to week 24

Trial details

NCT IDNCT00367770

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-12

Results submitted2016-04-11

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.