This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
822
Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.
Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.
Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.
Investigative Site
Sorocaba, Brazil
Investigative Site
Gatineau, Canada
Investigative Site
Guayaquil, Ecuador
Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
Time frame: 12 weeks, 13 weeks
Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
Time frame: 12 weeks, 13 weeks
Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.
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Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.
Investigative Site
Erfurt, Germany
Invesitagtive Site
Budapest, Hungary
Investigative Site
Kuala Lumpur, Malaysia
Investigative Site
Mexico City, Mexico
Investigative Site
Panama City, Panama
Investigative Site
Manila, Philippines
Investigative Site
Singapore, Singapore
...and 6 more locations
Time frame: Baseline, 13 weeks
Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period
Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis. The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate. The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.
Time frame: Baseline, 12 weeks, 13 weeks
Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period
Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis. The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate. The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.
Time frame: Baseline, 12 weeks, 13 weeks