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.       
    

NCT01518946_exc_T1
Condition
pregnant
NCT01518946_exc_T2
Condition
lactating
NCT01518946_exc_T3
Person
female
NCT01518946_exc_T4
Condition
supine hypertension
NCT01518946_exc_T5
Value
greater than 180mmHg systolic
NCT01518946_exc_T6
Value
110mmHg diastolic
NCT01518946_exc_T7
Measurement
BP
NCT01518946_exc_T8
Temporal
at the Screening Visit
NCT01518946_exc_T9
Reference_point
Screening Visit
NCT01518946_exc_T10
Temporal
pre-existing
NCT01518946_exc_T11
Temporal
sustained
NCT01518946_exc_T12
Scope
or at the Screening Visit sustained
NCT01518946_exc_T13
Temporal
persistently
NCT01518946_exc_T14
Value
greater
NCT01518946_exc_T15
Multiplier
2 separate at least 5 minutes apart
NCT01518946_exc_T16
Measurement
measurements
NCT01518946_exc_T17
Drug
medications of interest
NCT01518946_exc_T18
Temporal
concomitant
NCT01518946_exc_T23
Condition
chronic illness
NCT01518946_exc_T24
Condition
acute illness
NCT01518946_exc_T25
Condition
disability
NCT01518946_exc_T26
Condition
other condition
NCT01518946_exc_T28
Procedure
electrocardiogram [ECG]
NCT01518946_exc_T29
Condition
laboratory findings
NCT01518946_exc_T30
Condition
electrocardiogram [ECG] findings
NCT01518946_exc_T32
Condition
enrollment failure
NCT01518946_exc_T34
Condition
alcohol abuse
NCT01518946_exc_T35
Condition
substance abuse
NCT01518946_exc_T36
Temporal
within the last year
NCT01518946_exc_T37
Scope
alcohol abuse or other substance abuse