Trial record 5 of 24 for:    Open Studies | "Hypotension, Orthostatic"

Droxidopa / Pyridostigmine in Orthostatic Hypotension

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Mayo Clinic
Information provided by (Responsible Party):
Phillip Low, Mayo Clinic Identifier:
First received: June 8, 2011
Last updated: January 4, 2016
Last verified: January 2016
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: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01370512

Contact: Tonette Gehrking 507-284-0336

United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tonette Gehrking    507-284-0336   
Principal Investigator: Phillip A. Low, MD         
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Phillip Low, PI, Mayo Clinic Identifier: NCT01370512     History of Changes
Other Study ID Numbers: 10-008810 
Study First Received: June 8, 2011
Last Updated: January 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotension, Orthostatic
Autonomic Nervous System Diseases
Cardiovascular Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Vascular Diseases
Pyridostigmine Bromide
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 02, 2016