This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
818
Aliskiren 300 mg tablet taken orally once a day with a glass of water.
Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
Investigative site
Estonia, Estonia
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France, France
Investigative Site
Iceland, Iceland
Investigative Site
India, India
Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor 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. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
Time frame: Baseline, End of Study (Week 8)
Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor 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. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.
Time frame: Baseline, End of Study (Week 8)
Number of Participants With Serious Adverse Events and Adverse Events
The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class. Additional information about Adverse Events can be found in the Adverse Event Section.
Time frame: 8 weeks
Percentage of Participants Achieving Blood Pressure Control
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 the automatic Blood Pressure monitor 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. Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure \<90 and a mean sitting Systolic Blood Pressure \<140.
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Placebo to Aliskiren tablet taken orally once a day.
Placebo to Aliskiren/Amlodipine taken orally once a day.
Investigative site
Italy, Italy
Investigative Site
Lithuania, Lithuania
Investigative Site
Republic of Korea, South Korea
Investigative Site
Spain, Spain
Investigative Site
Venezuela, Venezuela
Time frame: 8 weeks
Percentage of Participants Achieving a Diastolic Blood Pressure Response
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 the automatic Blood Pressure monitor 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 Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) \<90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline.
Time frame: 8 weeks
Percentage of Participants Achieving a Systolic Blood Pressure Response
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 the automatic Blood Pressure monitor 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 Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) \<140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline.
Time frame: 8 weeks