Gilead begins enrolling into Ph II trial of cicletanine

US drugmaker Gilead Sciences has begun enrolling patients in a Phase II trial of cicletanine HCl, an oral agent in development for the treatment  of pulmonary arterial hypertension.

The study is designed to compare the efficacy, safety and tolerability  of cicletanine to placebo in patients with PAH and will enroll 160  patients at approximately 60 investigational sites worldwide.

The study is a randomized, double-blind, placebo-controlled,  multicenter, dose-ranging evaluation designed to test the safety,  efficacy and tolerability of cicletanine for the treatment of PAH. The  primary efficacy endpoint is the change from baseline in six-minute walk  distance 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, a measure of breathing ability.