Myogen achieves enrollment for phase-3b trial of ambrisentan to treat hypertension

By Angela McDaniels

Seattle, Nov. 10 - Myogen Inc. said it has achieved its target enrollment of 186 patients in its phase-3b trial of ambrisentan in patients with pulmonary arterial hypertension.

The trial's primary efficacy endpoint is exercise capacity, measured as the mean change from baseline at 12 weeks in a six-minute walk test.

Results of the phase-2 trial of ambrisentan demonstrated significant improvements in six-minute walk distance, the company said.

The phase-3b trial enrolled patients primarily from North America and the earlier phase-3a trial enrolled patients primarily in Europe.

The two phase-3 trials are identical except for the doses of ambrisentan given and the geographic locations of the investigative sites.

The company expects to report results of the phase-3a trial in December and results from the phase-3b trial in the second quarter of 2006.

Ambrisentan has been granted orphan drug designation for the treatment of pulmonary arterial hypertension in both the United States and European Union, the company said.

Myogen is a Denver-based biopharmaceutical company that develops small-molecule therapeutics for the treatment of cardiovascular disorders.

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