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Article Excerpt
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), Charlotte, N.C., announced that it has initiated patient dosing in Study 301, the second of two pivotal Phase III trials designed to demonstrate efficacy and support U.S. marketing approval of Droxidopa in neurogenic orthostatic hypotension (NOH).
Study 301 is a multinational, randomized, placebo-controlled, induction-design Phase III trial evaluating up to 118 patients. The trial is approximately 4 weeks in duration and includes an initial open-label dose titration period of up to two weeks, after which patients undergo a 7-day washout period prior to randomization into a 7-day double-blind treatment period. During the open label dose titration period, all patients will be titrated to maximum therapeutic benefit with up to 600 mg t.i.d. of Droxidopa and must demonstrate both a blood pressure and symptomatic improvement. Patients not responding to treatment during the titration...
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