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Droxidopa / Pyridostigmine in Orthostatic Hypotension

This study is currently recruiting participants.
Verified July 2017 by Phillip Low, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370512
First Posted: June 10, 2011
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Phillip Low, Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Orthostatic Hypotension Drug: Droxidopa Drug: Pyridostigmine Bromide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension

Resource links provided by NLM:


Further study details as provided by Phillip Low, Mayo Clinic:

Primary Outcome Measures:
  • The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing. [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Droxidopa / Pyridostigmine Drug: Droxidopa
100 mg t.i.d. for 2 days; then 200 mg t.i.d. for another 2 days
Drug: Pyridostigmine Bromide
180 mg daily for 4 days
Placebo Comparator: Droxidopa Drug: Droxidopa
100 mg t.i.d. for 2 days; then 200 mg t.i.d. for another 2 days
Placebo Comparator: Pyridostigmine Drug: Pyridostigmine Bromide
180 mg daily for 4 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370512


Contacts
Contact: Tonette Gehrking 507-284-0336 adc.research@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tonette Gehrking    507-284-0336    adc.research@mayo.edu   
Principal Investigator: Phillip A. Low, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Phillip A Low, M.D. Mayo Clinic
  More Information

Responsible Party: Phillip Low, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01370512     History of Changes
Other Study ID Numbers: 10-008810
First Submitted: June 8, 2011
First Posted: June 10, 2011
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Bromides
Droxidopa
Pyridostigmine Bromide
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs