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CoTherix initiates combination trial of PAH drug

CoTherix has initiated a phase III trial of Ventavis inhalation solution in combination with sildenafil citrate for the treatment of pulmonary arterial hypertension.

Ventavis is approved and marketed in the US for the treatment of pulmonary arterial hypertension (PAH), a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs.

The clinical trial is a double-blind, placebo-controlled trial, in which approximately 180 pulmonary arterial hypertension patients treated with a stable dose of oral sildenafil (a PDE-5 inhibitor and the active ingredient in Pfizer’s Viagra) will be randomized to one of three treatment groups for 16 weeks: Ventavis four doses per day, Ventavis six doses per day, or placebo.

The primary clinical endpoint of the trial is an increase in the distance walked in six minutes. Improvement in New York Heart Association functional class, a delay in clinical deterioration, hemodynamics and safety will also be evaluated.