Phase 2 study of cicletanine for pulmonary arterial hypertension

Gilead Sciences announced that it has begun enrolling patients in a Phase 2 clinical trial of cicletanine hydrochloride, an oral agent in development for the treatment of pulmonary arterial hypertension (PAH). This randomized, double-blind, placebo-controlled study will compare the efficacy, safety and tolerability of cicletanine to placebo in 160 patients with PAH. The primary efficacy endpoint is the change from baseline in six-minute walk distance (6MWD) after 12 weeks of treatment. Secondary endpoints include time to clinical worsening of PAH during the 12-week placebo-controlled treatment period and change from baseline after 12 weeks in Borg dyspnea index (BDI, a measure of breathing ability), WHO functional class, SF-36® Health Survey physical functioning scale and various hemodynamic measures.

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