Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension
Condition: Hypotension, Orthostatic
MeSH terms: Hypotension, Orthostatic; Hypotension
Intervention: Midodrine hydrochloride; Placebo
Intervention description: one dose, 10-30mg, given orally; Placebo
Intervention MeSH terms: Midodrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to evaluate the clinical effect of midodrine
      hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by
      measuring the time to onset of near syncopal symptoms and assessing several cardiovascular
      measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The male or female subjects must be 18 years of age or older and ambulatory. (Subjects
             must not require assistance with a walker or wheelchair to perform regular daily
             activities at all times.)

          -  Women of childbearing potential must have a negative serum beta HCG pregnancy test at
             screening and baseline.

          -  The subject has been diagnosed with symptomatic orthostatic hypotension due to
             Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic
             neuropathy (i.e. neurogenic orthostatic hypotension).

          -  The subject manifests one of the following symptoms while standing or has a history of
             one of the following when not treated for orthostatic hypotension: dizziness,
             lightheadedness, feeling faint or feeling like they may black out.

          -  The subject is willing and able to undergo the procedures required by this protocol
             including morning office visits, assessment completion, protocol compliance and
             participation in the wash-out period.

          -  The subject has signed an Institutional-Review-Board approved written informed consent
             form prior to any study procedures taking place.

        Exclusion Criteria:

          -  The subject is a pregnant or lactating female.

          -  The subject has pre-existing sustained supine hypertension greater than 180 mm Hg
             systolic and 110 mm Hg diastolic.

          -  The subject is taking medications such as vasodilators, pressors, diuretics, ACE
             inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and
             beta-blockers, MAOI's, herbals or specific mixed effect medications.

          -  The Principal Investigator deems any laboratory test abnormality clinical significant.

          -  The subject has a diagnosis of any of the following disorders at the time of
             screening: pheochromocytoma; cardiac conditions including: congestive heart failure
             within the previous 6 months, myocardial infarction within the previous 6 months,
             symptomatic coronary artery disease, history of ventricular tachycardia, or
             uncontrolled cardiac arrhythmias; thyrotoxicosis; uncontrolled diabetes mellitus
             (uncontrolled defined as a HgbA1c greater than or equal to 10%); history of
             cerebrovascular accident, transient ischemic attack (TIA) or symptomatic carotid
             artery stenosis within the previous 6 months; history of coagulopathies; pulmonary
             hypertension; severe psychiatric disorders; renal failure (Creatinine equal to or
             greater than 2 times the upper limit of normal)

          -  The subject has a concurrent chronic or acute illness, disability, or other condition
             that might confound the results of the tests and/or measurements administered in this
             trial, or that might increase the risk to the subject.