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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
June 8, 2011
June 10, 2011
August 1, 2017
November 2011
June 2018   (Final data collection date for primary outcome measure)
The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing. [ Time Frame: 7 days ]
The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing. [ Time Frame: 6 days ]
Complete list of historical versions of study NCT01370512 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Droxidopa / Pyridostigmine in Orthostatic Hypotension
Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Orthostatic Hypotension
  • 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
  • Active Comparator: Droxidopa / Pyridostigmine
    Interventions:
    • Drug: Droxidopa
    • Drug: Pyridostigmine Bromide
  • Placebo Comparator: Droxidopa
    Intervention: Drug: Droxidopa
  • Placebo Comparator: Pyridostigmine
    Intervention: Drug: Pyridostigmine Bromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
June 2018
June 2018   (Final data collection date for primary outcome measure)
  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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Tonette Gehrking 507-284-0336 adc.research@mayo.edu
United States
 
 
NCT01370512
10-008810
No
Not Provided
Not Provided
Phillip Low, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Phillip A Low, M.D. Mayo Clinic
Mayo Clinic
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP