Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
The purpose of this study is to determine whether midodrine works against the symptoms of
 orthostatic hypotension caused by being on a tilt table.
The efficacy of midodrine will be assessed in those subjects who have severe symptoms of
 orthostatic hypotension when not taking midodrine and are controlled when taking midodrine.
 The study will involve approximately 4 overnight stays.
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.