Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood
pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well
as reducing the severity and frequency of symptoms of orthostatic hypotension in these
patients. The efficacy of droxidopa in ameliorating symptoms in patients undergoing dialysis
has also been demonstrated in the literature and clinical trials conducted in Japan. The
current study will investigate the clinical efficacy of two different doses of droxidopa in
patients with intradialytic hypotension over a 4 week treatment period with a placebo
control. The clinical efficacy will be evaluated by changes in hypotension- related symptoms,
as well as changes in blood pressure prior to, during and following, HD sessions as compared
to their pre-treatment baseline values.