Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension

Who is this study for? Patients with Orthostatic Hypotension
Status: Completed
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The hypothesis is that pyridostigmine will improve the safety factor of ganglionic neural transmission, while Droxidopa will replete the postganglionic neuron of norepinephrine (NE). This combination should result in enhanced orthostatic release of NE. The investigators have already demonstrated that pyridostigmine does not raise supine blood pressure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• The presence of OH (fall in systolic BP >=30 mm Hg) is required for this study.

• Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.

Locations
United States
Minnesota
Mayo Clinic in Rochester
Rochester
Time Frame
Start Date: November 2011
Completion Date: January 19, 2021
Participants
Target number of participants: 23
Treatments
Experimental: droxidopa plus pyridostigmine
droxidopa 100mg by mouth three times a day plus pyridostigmine 60mg by mouth three times a day (one day)
Active Comparator: droxidopa
droxidopa 100mg by mouth three times a day plus placebo (for pyridostigmine) by mouth three times a day (one day)
Active Comparator: pyridostigmine
pyridostigmine 60mg by mouth three times a day plus placebo (for droxidopa) by mouth three times a day
Placebo Comparator: placebo
placebo (for pyridostigmine) by mouth three times a day plus placebo (for droxidopa) by mouth three times a day
Sponsors
Leads: Mayo Clinic
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov

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