Droxidopa / Pyridostigmine in Orthostatic Hypotension

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Phillip Low, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01370512
First received: June 8, 2011
Last updated: January 30, 2014
Last verified: January 2014

June 8, 2011
January 30, 2014
November 2011
June 2015   (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 ] [ Designated as safety issue: Yes ]
The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
  • Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine versus placebo on supine NE and its orthostatic increment. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
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: Double Blind (Subject, Caregiver, 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 2015
June 2015   (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.
Both
18 Years and older
No
Contact: Tonette Gehrking 507-284-0336 adc.research@mayo.edu
United States
 
NCT01370512
10-008810
No
Phillip Low, Mayo Clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
January 2014

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