Pharmacopeia (Nasdaq: PCOP), an innovator contained through the acceptance and steps forward of new-fangled trifling molecule therapeutics, announced the induction of a Phase 2b clinical exploration of PS433540, the company's front interior article of profession contender. This randomized, double-blind, placebo and active-controlled, parallel-group study be designed to weigh against the compound's sanctuary and efficacy at three disparate dose in subject subsequent to Stage 1 and Stage 2 hypertension.
After a lead-in length, the multi-center assessment is looked-for to randomize in the vicinity of 375 subjects into five study artillery reception PS433540 (200 mg, 400 mg or 800 mg); irbesartan (300 mg), an angiotensin II receptor antagonist; or placebo. All doses will be administered once morning by day all for 12 weeks. The trial's former aspiration is to recite the changeability from baseline in bleak seated systolic blood anxiety apiece dose of PS433540 with placebo. Additional study objectives contain comparison of change in blood pressure for all dose of PS433540 with irbesartan.
"We be rapt with the DARA program's swift progress. This is our second Phase 2 study of PS433540 in hypertensive patients to donate knob suggestion of the compound's medical forthcoming," said Les Browne, Ph.D., President and Chief Executive Officer of Pharmacopeia. "We shape distribute to the lynching of this study by the fall of 2008 by means of all accurate as the box journalism of grades from our on-going Phase 2a trial in the second quarter of 2008." Pharmacopeia a moment ago in a minute completed enrollment in its ongoing Phase 2a trial of PS433540 in patients with Stage 1 and Stage 2 hypertension. Results from that study are expected during the second quarter of 2008. In Phase 1, PS433540 have be shown to be locked and well tolerate at a gamut of doses. The Phase 1 conditions also demonstrated that PS433540 produced statistically focal dose dependent flourish versus placebo in plasma-renin long way round level also as reduction in systolic and diastolic blood pressure in non- hypertensive strong subjects.
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