FDAnews
www.fdanews.com/articles/108570-drug-meets-safety-goals-in-cleviprex-study

Drug Meets Safety Goals in Cleviprex Study

July 15, 2008

A Phase III trial for The Medicines Company’s investigational agent Cleviprex demonstrated that the drug is effective and safe for the rapid treatment of acute hypertension after cardiac surgery.

The randomized, double-blind, placebo-controlled trial examined the efficacy and safety of the drug in 110 patients with a systolic blood pressure greater than 140 mm Hg following cardiac surgery. The study showed a treatment success rate of 91.8 percent compared with 20.4 percent for the placebo group, according to the company.

Cleviprex is a novel investigational IV antihypertensive for acute blood pressure management. It is intended for use when oral therapy is not feasible or desirable, the company said.