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Droxidopa / Pyridostigmine in Orthostatic Hypotension

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Orthostatic Hypotension

Intervention: Droxidopa (Drug); Pyridostigmine Bromide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Mayo Clinic

Overall contact:
Tonette Gehrking, Phone: 507-284-0336, Email: adc.research@mayo.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing.

Secondary outcome:

Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine versus placebo on supine NE and its orthostatic increment.

Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

1. The presence of orthostatic hypotension (fall in systolic BP greater than or equal to 30 mm Hg) is required for this study; 2. Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.

Locations and Contacts

Tonette Gehrking, Phone: 507-284-0336, Email: adc.research@mayo.edu

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Tonette Gehrking, Phone: 507-284-0336, Email: adc.research@mayo.edu
Phillip A. Low, MD, Principal Investigator
Additional Information

Starting date: November 2011
Last updated: May 14, 2015

Page last updated: August 23, 2015

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