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Enrolling by invitationPhase 2

Tests droxidopa with pyridostigmine for low blood pressure on standing

Tests two drugs in adults with a drop in blood pressure on standing.

Plain-language title generated from the registry record
Registry title: Droxidopa / Pyridostigmine in Orthostatic Hypotension

Key facts

Where
Rochester, United StatesSee the site
Phase
Phase 2

Where in United States

  • Mayo Clinic in RochesterRochester, United StatesNo longer taking part

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  4. What happens if I want to stop?
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Trial details

Who runs it
Mayo Clinic
Trial code
NCT01370512
Record updated
15 July 2026
Original description
This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.Read full original descriptionShow less

Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension

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

Inclusion: The presence of OH (fall in systolic BP >=30 mm Hg) is required for this study; Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.

Exclusion: Any known concurrent infection or severe liver or kidney disease; Medications that could affect autonomic function are suspended prior to autonomic testing. Therapy with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations. Fludrocortisone doses up to 0.2 mg per day will be permitted. Stable doses of antidepressants (tricyclics, SSRIs, SNRIs) will also be permitted. The 48h medication withdrawal is reviewed on a case by case basis - if felt unsafe by the investigators, the withdrawal period may be shortened. This will be documented in the study documents; Occasional use of a neuroleptic as an anti-emetic in the past is allowed, but none can have been used within 3 weeks prior to this study; Use of methylphenidate, cinnarizine, reserpine, amphetamine, atypical antipsychotics such as risperidone, olanzapine, and quetiapine or a MAO-A inhibitor within 3 weeks prior to this study; Chronic illnesses or the presence of other conditions that potentially involve the CNS or affect autonomic testing. These include congestive heart failure, recent (<6 months) myocardial infarct, severe anemia, diabetes mellitus, alcoholism, malignant neoplasms, amyloidosis, hypothyroidism, sympathectomy, cerebrovascular accidents, and neurotoxins or neuroactive drug exposure; Orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living; Dementia (DSM-IV criteria - Amer. Psych. Assoc., 1994). The score on the Mini-Mental State Examination must be >24; History of stroke (diagnosed on clinical grounds as an acute deterioration of neurological function typical of a stroke; confirmatory CT or MRI evidence of stroke will be useful but not necessary); History of electroconvulsive therapy; History of brain surgery for Parkinson's disease; Pregnant or lactating females.

ClinicalTrials.gov NCT01370512