CompletedPhase 4

Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

54 participantsStarted 2003-09

Plain-language summary

This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology. Patients receive bosentan or placebo for 16 weeks.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Male or female patients at least 12 years with a body weight at least 40 kg (inclusive) and with a functional class III (1998 WHO classification).
✓. Patients with pulmonary arterial hypertension related to Eisenmenger physiology echocardiographically established as atrial septal defect at least 2 cm effective diameter and/or ventricular septal defect at least 1 cm effective diameter; PAH confirmed via cardiac catheterization: mean pulmonary arterial pressure \>25 mm Hg, pulmonary capillary wedge pressure \<15 mm Hg and pulmonary vascular resistance \>3 mm Hg/l/min.
✓. Patients with documented oxygen saturation up to 90%, and \>70% (at rest, with room air).
✓. Patients able to perform a 6-minute walk test at least 150 m, and up to 450 m.
✓. Patients stable for at least 3 months prior to screening.
✓. Bosentan naïve patients.
✓. Female patients who are surgically sterile, postmenopausal or have documented infertility.
✓. Female patients 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.

Exclusion criteria

✕. Pregnant patients, nursing mothers.
✕. Patients with left ventricular dysfunction (ejection fraction \<40%).
✕. Patients with restrictive lung disease (TLC\<70% predicted); obstructive lung disease (FEV1\<70% predicted, with FEV1/FVC\<60%)
✕. Patients with systolic blood pressure \< 85 mm Hg.
✕. Patients with other conditions that may affect the ability to perform a 6-minute walk test.
✕. Patients unable to provide informed consent and comply with the patient protocol.
✕. Patients with known coronary arterial disease.
✕. Patients with serum creatinine \>125 µM/l.

What they're measuring

Change from baseline to Week 16 in oxygen saturation at rest with room air

Change from baseline to Week 16 in indexed pulmonary vascular resistance

Trial details

NCT IDNCT00317486

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-04

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