drugset / Trial / NCT01132326

Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)

NCT01132326

Phase 3 Completed 350 enrolled Chelsea Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge resulting in symptomatic cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of NOH. The present study will evaluate the long-term safety of droxidopa.

Timeline

Start
2009-01
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Droxidopa Small molecule 100 mg Oral
Subject Droxidopa Small molecule 200 mg Oral
Subject Droxidopa Small molecule 300 mg Oral
Subject Droxidopa Small molecule 400 mg Oral
Subject Droxidopa Small molecule 500 mg Oral
Subject Droxidopa Small molecule 600 mg Oral