To evaluate the efficacy of droxidopa in patients with symptomatic NOH as measured by the relative change in mean score of the composite Orthostatic Hypotension Questionnaire(OHQ) 7 days following randomization to treatment with droxidopa or placebo. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Evaluate efficacy of droxidopa as measured by changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements 3 minutes post standing; [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Perhaps it was short and small study because of the orphan status, the fact that the fda intended to pull midodrine off the market, and because the guidance in the spa dictated the size/duration were acceptable for approval.