Clinical Trial: Droxidopa / Pyridostigmine in Orthostatic Hypotension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
Brief 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.
Detailed Summary:
Sponsor: Mayo Clinic
Current Primary Outcome: The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing. [ Time Frame: 7 days ]
Original Primary Outcome: The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing. [ Time Frame: 6 days ]
Current Secondary Outcome:
- Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine versus placebo on supine NE and its orthostatic increment. [ Time Frame: 7 days ]
- Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms. [ Time Frame: 7 days ]
Original Secondary Outcome:
- Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine versus placebo on supine NE and its orthostatic increment. [ Time Frame: 6 days ]
- Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms. [ Time Frame: 6 days ]
Information By: Mayo Clinic
Dates:
Date Received: June 8, 2011
Date Started: November 2011
Date Completion: June 2017
Last Updated: September 12, 2016
Last Verified: September 2016
