Gilead Sciences, Inc. Announces Plans for Phase IV Clinical Trial Evaluating First-Line Combination Therapy Versus Monotherapy in Pulmonary Arterial Hypertension

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD), in collaboration with GlaxoSmithKline (GSK), today announced plans for an international, event-driven (morbidity and mortality) clinical trial to study combination therapy versus monotherapy in a first-line treatment setting for pulmonary arterial hypertension (PAH). The study, AMBITION (a randomized, double-blind, multicenter study of first-line combination therapy with AMBrIsentan and Tadalafil in subjects with pulmonary arterial hypertensION), will evaluate first-line combination use with ambrisentan, an endothelin receptor antagonist (ERA) and tadalafil, a PDE5 inhibitor, in patients with PAH. Ambrisentan is approved under the tradename Letairis® (ambrisentan 5 mg and 10 mg tablets) as a once-daily treatment for PAH (WHO Group 1) in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening.

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