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12:00 AM
Feb 07, 2011
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Northera droxidopa: Phase III amended

Chelsea said it will amend the double-blind Phase III Study 306 trial after an independent DMC said that Northera would not meet the primary endpoint of significantly improving OHQ composite score vs. placebo. Specifically, an interim analysis of 51 patients showed that Northera improved OHQ composite score by a mean of 2.3 units from baseline to week 8 vs. 2.1 units for placebo. The company said the "true benefit" of Northera was confounded by a highly variable and larger-than-expected placebo response.

Chelsea plans to use the data from the 306 trial, which are expected in 2Q12, to serve as the...

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