Droxidopa / Pyridostigmine in Orthostatic Hypotension

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT01370512
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Orthostatic Hypotension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Droxidopa — DRUG
    100 mg tablets by mouth three times a day
  • Pyridostigmine — DRUG
    60 mg tablets by mouth three times a day
  • Placebo — OTHER
    Looks exactly like the study drug but contains no active ingredients

Study Details

This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.

Key Dates

Start date
Nov 30, 2011
Status verified
Jul 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Placebo, Then Pyridostigmine
    participants first receive placebo by mouth 3 times a day, for treatment day 1. Then participants receive pyridostigmine by mouth 3 times a day for treatment day 2.
  • Active Comparator: Pyridostigmine, Then Placebo
    participants first receive pyridostigmine by mouth 3 times a day, for treatment day 1. Then participants receive placebo by mouth 3 times a day for treatment day 2.
  • Experimental: Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine
    participants first receive placebo by mouth 3 times a day, for treatment day 3. Then participants receive Droxidopa by mouth 3 times a day for treatment day 4.
  • Experimental: Droxidopa and Pyridostigmine, Then Droxidopa and Placebo
    participants first receive Droxidopa by mouth 3 times a day, for treatment day 3. Then participants receive Placebo by mouth 3 times a day for treatment day 4.

Primary Outcome Measure

Change in orthostatic diastolic blood pressure [ Time Frame: 1 hour after medication administration, 2 hours after medication administration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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Mayo Clinic in Rochester· Rochester, MN

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