ENROLLMENT COMPLETED FOR PHASE III HYPERTENSION TRIALS
Myogen, has announced the completion of enrollment of 187 patients in ARIES-2, one of the company's two pivotal Phase III trials of ambrisentan in patients with pulmonary arterial hypertension (PAH). Top line results of the trial are expected to be reported by the end of this year.
In January 2004, Myogen initiated two pivotal Phase III clinical trials, ARIES-1 and ARIES-2, evaluating the safety and efficacy of ambrisentan in patients with PAH. The ARIES trials are randomized, double-blind, placebo-controlled trials of identical design except for the doses of ambrisentan and the geographic locations of the investigative sites. Both trials are designed to enroll 186 patients (62 patients per dose group). ARIES-1 evaluates doses of 5.0 milligrams and 10.0 milligrams of ambrisentan administered orally once per day and ARIES-2 evaluates doses of 2.5 milligrams and 5.0 milligrams of ambrisentan administered orally once per day.
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