| Outcome Measures: |
Primary: Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8, The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24., baseline, week 8 | Secondary: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP), Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit., Baseline, week 8|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8, The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24., baseline, week 8|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8, The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits., baseline, week 8|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP), Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit., Baseline, week 8|Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8, At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement., baseline, week 8|Percentage of Patients Achieving Blood Pressure Control, Blood pressure control was defined as MSSBP/MSDBP \<140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported, 8 weeks|Percentage of Responders, Responders were defined as patients with MSSBP \<130 mmHg or a reduction from baseline in MSSBP of \>20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported., Baseline, Week 8|Change From Baseline in Plasma Renin Activity (PRA) at Week 8, Baseline, week 8|Change From Baseline in Plasma Renin Concentration (PRC) at Week 8, Baseline, week 8|Change From Baseline in Plasma Aldosterone at Week 8, Baseline, week 8|Number of Patients With Adverse Events, Serious Adverse Events and Death, Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards., 8 weeks
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| Locations: |
Investigative Site, Newark, Delaware, USA, United States|Investigative Site, Kansas, Missouri, United States|Investigative Site, Camden, New Jersey, United States|Investigative Site, Philadelphia, Pennsylvania, United States
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