Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
Condition: Symptomatic Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Hypotension
Intervention: Midodrine HCl; Placebo
Intervention description: dose at subject's current dose level; single dose of matching placebo
Intervention MeSH terms: Midodrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To study the effect of midodrine against the symptoms of orthostatic hypotension
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects must be 18 years of age or older and ambulatory.

          2. Females of child-bearing potential (FOCP) must have a negative serum beta human
             chorionic gonadotropin (HCG) pregnancy test.

          3. A documented history of severe Symptomatic Orthostatic Hypotension (SOH) that, in the
             judgment of the treating physician, has required treatment with midodrine HCl, and has
             been at a stable dose for at least 3 months.

          4. The subject has manifested at least 1 of the following symptoms while standing or had
             a medical history of 1 of the following when not treated for orthostatic hypotension
             (OH): dizziness, lightheadedness, feeling faint, or feeling like they might black out.

        Exclusion criteria

          1. The subject is a pregnant or lactating female.

          2. The subject has pre-existing sustained supine hypertension greater than 180mmHg
             systolic and 110mmHg diastolic BP or had these measurements at the Screening Visit.
             Sustained is defined as persistently greater at 2 separate measurements at least 5
             minutes apart with the subject supine and at rest for the 5 minutes.

          3. Subjects taking concomitant medications of interest are excluded unless those
             medications are reviewed and discussed with the Medical Monitor or Study Physician and
             documented prior to enrolling the subject. If agreement is reached between the
             Investigator and Sponsor for the subject to continue in the study, all allowed
             medications should be maintained at a constant dose throughout the study.

          4. The Principal Investigator deems any clinical laboratory test (at the Screening Visit)
             abnormality to be clinically significant

          5. The subject has participated in other studies of investigational drugs or devices
             within 30 days prior to enrollment in this study (other than Study SPD426-406).

          6. Current or relevant history of physical or psychiatric illness, any medical disorder
             that may require treatment or make the subject unlikely to fully comply with the
             requirements of the study or complete the study, or any condition that presents undue
             risk from the investigational product or study procedures.

          7. The subject has a concurrent chronic or acute illness, disability, or other condition
             (including significant unexpected laboratory or electrocardiogram [ECG] findings) that
             might confound the results of the tests and/or measurements administered in this
             study, or that might have increased the risk to the subject.

          8. Known or suspected intolerance or hypersensitivity to the investigational product(s),
             closely-related compounds, or any of the stated ingredients.

          9. Prior enrollment failure or randomization in this study.

         10. History of alcohol abuse or other substance abuse within the last year.