Chelsea completes enrollment in Ph Iintradialytic hypotension trial

USA-based Chelsea Therapeutics has completed patient enrollment in its Phase II trial of droxidopa, an orally-active synthetic precursor of norepinephrine, in intradialytic hypotension.

The multicenter, double-blind, placebo-controlled trial is a dose response study comparing 400mg and 600mg of droxidopa to placebo in a total of 75 patients. Following a two-week run-in period to establish baseline, patients in this three-arm study will receive a single oral dose of droxidopa or placebo one hour prior to each dialysis treatment over a four-week period (approximately 12 dialysis sessions). The study will compare the change in mean blood pressure and symptomatic improvement during the final two weeks of treatment to baseline established prior to drug treatment.

The agent is Chelsea's most advanced investigational product and is currently in development for the treatment of neurogenic orthostatic hypotension as its lead indication. The firm plans to seek its first marketing approval for droxidopa in NOH following the completion of its pivotal Phase III program in mid-2009.