This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
328
Aliskiren supplied in 150 mg and 300 mg tablets.
Placebo to Aliskiren matching 150 and 300 mg tablets
Investigative Site
Zanesville, Ohio, United States
Investigative Site
Frankfurt, Germany
Investigative Site
Valencia, Spain
Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.
Time frame: Baseline, Week 6
Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.
Time frame: Baseline, Week 6
Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.
Time frame: Baseline, Week 6
Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.
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Time frame: Baseline, Week 6
Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. 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 blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate.
Time frame: Baseline, Week 6
Percentage of Participants Achieving Blood Pressure Control at Week 6
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) \<90 mm Hg and a mean sitting systolic blood pressure (msSBP) \<140 mm Hg.
Time frame: Week 6
Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) \<90 mm Hg and a mean sitting systolic blood pressure (msSBP) \<140 mm Hg.
Time frame: Week 10