Gilead Sciences (GILD) and Glaxo (GSK) Announce Pulmonary Arterial Hypertension Clinical Trial
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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.
AMBITION will be a double-blind, multicenter study, in which more than 300 treatment-naive PAH patients will be randomized to receive either the combination of ambrisentan and tadalafil or monotherapy (ambrisentan or tadalafil). Gilead and GSK are working with regulatory agencies and the PAH research community to finalize details of the study and plan to begin enrollment in 2010.
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