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news.Pharmacopeia has completed recruitment in the company's multi-center Phase IIa clinical study of PS433540 or Dara, the company's lead internal product candidate.
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The objective of the Phase IIa randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of 200 and 500mg of PS433540 in subjects with Stage I and Stage II hypertension.
Results from Phase I studies of PS433540 in normal subjects have indicated that the compound was well tolerated at all doses up to and including 1,000mg a day for 14 days. PS433540 is a dual-acting angiotensin and endothelin receptor antagonist that is being developed as a potential treatment for hypertension and diabetic nephropathy.
Les Browne, president and CEO of Pharmacopeia, said: “As this is the first PS433540 study to include hypertensive patients, we are pleased to have the opportunity to demonstrate that Dara can effectively lower blood pressure in this patient population.”