MYOGEN LAUNCHES TRIAL OF AMBRISENTAN IN PATIENTS WITH PH

Myogen has initiated ARIES-3 (AMB-323), a Phase III long-term, open-label safety and efficacy study of ambrisentan in a broad population of patients with pulmonary hypertension (PH).

The primary objective of this study is to evaluate the effect of ambrisentan on exercise capacity in a broad population of patients with PH. The primary endpoint of the trial is the change from baseline in six-minute walk distance at week 24. Secondary endpoints include: clinical worsening of pulmonary hypertension, change from baseline in World Health Organization functional class, SF-36 health survey and the Borg dyspnea index.

ARIES-3 will enroll up to 200 patients in PH subgroups, including: PH associated with interstitial lung disease; PH due to chronic thromboembolic disease or sickle cell disease; PH associated with chronic obstructive pulmonary disease; pulmonary arterial hypertension (PAH) associated with congenital heart defects; and PAH associated with HIV infection. The trial will also enroll patients with PAH receiving prostacyclin or sildenafil therapy at baseline, and patients who previously discontinued either bosentan or sitaxsentan, or both, due to liver function test abnormalities.