CoTherix kick starts Ventavis trial in combination with Sildenafil for PAH
CoTherix, Inc. has initiated a Phase III trial of Ventavis (iloprost) Inhalation Solution in combination with sildenafil citrate. The trial will evaluate the safety and efficacy of Ventavis in combination with sildenafil for the treatment of pulmonary arterial hypertension (PAH). The trial will also include an arm to explore the efficacy of less frequent Ventavis dosing as suggested by peer-reviewed publications.
The clinical trial, called VISION (Ventavis Inhalation with Sildenafil to Improve and Optimize Pulmonary Arterial HypertensioN), is a double-blind, placebo-controlled trial, in which approximately 180 PAH patients treated with a stable dose of oral sildenafil, a PDE-5 inhibitor, 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, according to the company release.
Ventavis is approved and marketed in the United States for the treatment of pulmonary arterial hypertension (WHO Group I), a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs, in patients with NYHA Class III or IV symptoms.
CoTherix, Inc. is a biopharmaceutical company focused on licensing, developing and commercializing therapeutic products for the treatment of cardiopulmonary and other chronic diseases, including PAH.