Encysive Begins Enrollment in Resistant Hypertension Trial
Encysive Pharmaceuticals announced that the first patient has been enrolled into its Phase II dose-ranging study of oral TBC3711, the company's next-generation, highly selective endothelin receptor antagonist for treating resistant hypertension. The 12-week, multicenter, randomized, double-blind, placebo-controlled study will evaluate four once-daily oral doses of TBC3711 in approximately 150 patients with diagnosed resistant hypertension.
Resistant hypertension patients enrolled in the Phase II study will be randomized to one of four double-blind TBC3711 treatment arms or a placebo arm. Each arm will consist of approximately 30 patients. All study arms will receive once-daily doses of either TBC3711 or placebo. TBC3711 or placebo will be given concomitantly with each patient's current antihypertensive regimen. Primary outcome data will consist of blood-pressure measurements taken pre-dose and two hours post-dose.
TBC3711 is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. TBC3711 is a next-generation endothelin A antagonist that possesses high oral bioavailability and is more selective and potent than Thelin (sitaxsentan sodium), Encysive's oral treatment for pulmonary arterial hypertension.