- Uncontrolled hypertension (> 135/> 85 mm Hg on three repeated measurements during the 6 weeks prior to enrollment on the study); this pertains to subjects with known diagnosis of hypertension; such subjects will have been invited to participate in the trial following successful treatment of their known hypertension; subjects with diagnosis of hypertension established at study entry will be considered cases of potential "white coat" hypertension; such subjects will be otherwise evaluated for protocol and randomized if they agree to be monitored for blood pressure (BP); if BP remains persistently elevated, subjects will be allowed to remain on-study for three months while undergoing antihypertensive therapy and monitoring; if, at the end of 3 months, subjects cannot demonstrate successful BP control as measured and documented locally, dosing will be suspended; such subjects will nevertheless be urged to complete 6-month off study evaluation, for intention to treat analysis