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news.Pharmacopeia has initiated a Phase IIb clinical study of PS433540, the company's lead internal product candidate for the treatment of hypertension and diabetic nephropathy.
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This randomized, double-blind, placebo and active-controlled, parallel-group study is designed to evaluate the compound’s safety and efficacy at three different doses in subjects with Stage I and Stage II hypertension. After a lead-in period, the multi-center trial is expected to randomize approximately 375 subjects into five study arms receiving PS433540 (200mg, 400mg or 800mg), irbesartan (300mg), an angiotensin II receptor antagonist, or placebo. All doses will be administered once daily for 12 weeks.
The trial’s primary objective is to compare the change from baseline in mean seated systolic blood pressure for each dose of PS433540 with placebo. Additional study objectives include comparisons of changes in blood pressure for each dose of PS433540 with irbesartan.
Les Browne, president and CEO of Pharmacopeia, said: “We look forward to the completion of this study by the end of 2008 as well as the reporting of results from our on-going Phase IIa trial in the second quarter of 2008.”