Hypertension
Conditions
Keywords
Hypertension, Aliskiren, Amlodipine
Brief summary
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.
Interventions
DRUGPlacebo
DRUGAliskiren 150 mg tablet
DRUGAliskiren 300 mg tablet
DRUGAmlodipine 5 mg capsule
DRUGAliskiren/amlodipine 150/5 mg tablet
DRUGAliskiren/amlodipine 150/10 mg tablet
DRUGAliskiren/amlodipine 300/5 mg tablet
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* msDBP ≥ 90 mmHg and \< 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201) * msDBP ≥ 95 mmHg and \< 110 mmHg at Visit 3 (Day 1 / randomization). * All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).
Exclusion criteria
* Severe hypertension * Pregnant or nursing (lactating) women * Women of child-bearing potential * Previous or current diagnosis of heart failure (NYHA Class II-IV). * Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1. * Uncontrolled Type 1 or Type 2 diabetes mellitus * Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures * History of malignancy within 5 years * History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | End of study (Week 8) | Blood pressure control defined as msSBP \< 140 mm Hg and msDBP \< 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | End of study (Week 8) | Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure \< 140 mmHg or a \>= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | End of study (Week 8) | Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure \< 90 mmHg or a \>=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
Countries
Argentina, Australia, Canada, Colombia, Denmark, Finland, Greece, Italy, Mexico, Panama, Peru, Romania, Russia, South Africa, Spain, Sweden, Taiwan, United States
Participant flow
Recruitment details
A total of 2694 patients enrolled in the single-blind, placebo run-in period (2 to 4 weeks) of the study. A total of 1688 patients were randomized into the double-blind treatment period (8 weeks). Three patients were mis-randomized, as they were discontinued from the single-blind period and were not treated in the double-blind period.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos. | 198 |
| Aliskiren 150 mg Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. | 195 |
| Aliskiren 300 mg Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. | 203 |
| Amlodipine 5 mg Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. | 185 |
| Amlodipine 10 mg Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg. | 181 |
| Aliskiren/Amlodipine 150/5 mg Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. | 181 |
| Aliskiren/Amlodipine 150/10 mg 150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. | 183 |
| Aliskiren/Amlodipine 300/5 mg Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. | 178 |
| Aliskiren/Amlodipine 300/10 mg Tablet 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. | 184 |
| Total | 1,688 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind:Randomized Period (8 Weeks) | Abnormal laboratory values | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Double-blind:Randomized Period (8 Weeks) | Abnormal test procedure results | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double-blind:Randomized Period (8 Weeks) | Administrative problems | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Double-blind:Randomized Period (8 Weeks) | Adverse Event | 3 | 3 | 1 | 2 | 7 | 3 | 4 | 1 | 4 |
| Double-blind:Randomized Period (8 Weeks) | Discont. single-blind, Mis- randomized | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Double-blind:Randomized Period (8 Weeks) | Lost to Follow-up | 0 | 2 | 4 | 1 | 2 | 2 | 0 | 3 | 1 |
| Double-blind:Randomized Period (8 Weeks) | Patient no longer needs study drug | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double-blind:Randomized Period (8 Weeks) | Patient withdrew consent | 4 | 2 | 4 | 3 | 4 | 4 | 3 | 2 | 4 |
| Double-blind:Randomized Period (8 Weeks) | Protocol deviation | 5 | 3 | 1 | 2 | 3 | 1 | 2 | 2 | 3 |
| Double-blind:Randomized Period (8 Weeks) | Unsatisfactory therapeutic effect | 17 | 8 | 8 | 4 | 2 | 2 | 1 | 1 | 2 |
| Single-blind Period (2 to 4 Weeks) | Abnormal laboratory value(s) | 38 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Single-blind Period (2 to 4 Weeks) | Abnormal test procedure result(s) | 810 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Single-blind Period (2 to 4 Weeks) | Administrative problems | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Single-blind Period (2 to 4 Weeks) | Adverse Event | 35 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Single-blind Period (2 to 4 Weeks) | Lost to Follow-up | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Single-blind Period (2 to 4 Weeks) | Patient withdrew consent | 86 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Single-blind Period (2 to 4 Weeks) | Protocol deviation | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Aliskiren 150 mg | Aliskiren 300 mg | Amlodipine 5 mg | Amlodipine 10 mg | Aliskiren/Amlodipine 150/5 mg | Aliskiren/Amlodipine 150/10 mg | Aliskiren/Amlodipine 300/5 mg | Aliskiren/Amlodipine 300/10 mg Tablet | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | 53.7 years STANDARD_DEVIATION 10.32 | 54.3 years STANDARD_DEVIATION 11.07 | 54.0 years STANDARD_DEVIATION 9.99 | 54.2 years STANDARD_DEVIATION 11.61 | 55.0 years STANDARD_DEVIATION 10.34 | 53.9 years STANDARD_DEVIATION 10.82 | 53.0 years STANDARD_DEVIATION 10.59 | 54.8 years STANDARD_DEVIATION 10.29 | 54.4 years STANDARD_DEVIATION 10.86 | 54.1 years STANDARD_DEVIATION 10.65 |
| Sex: Female, Male Female | 108 Participants | 76 Participants | 108 Participants | 86 Participants | 94 Participants | 84 Participants | 96 Participants | 100 Participants | 78 Participants | 830 Participants |
| Sex: Female, Male Male | 90 Participants | 119 Participants | 95 Participants | 99 Participants | 87 Participants | 97 Participants | 87 Participants | 78 Participants | 106 Participants | 858 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 198 | 15 / 194 | 18 / 203 | 18 / 185 | 32 / 181 | 15 / 181 | 19 / 181 | 8 / 178 | 30 / 184 |
| serious Total, serious adverse events | 2 / 198 | 0 / 194 | 0 / 203 | 1 / 185 | 1 / 181 | 1 / 181 | 2 / 181 | 1 / 178 | 1 / 184 |
Outcome results
Primary
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -7.99 mm Hg | Standard Error 0.63 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -16.16 mm Hg | Standard Error 0.66 |
p-value: <0.00195% CI: [-9.94, -6.4]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -13.82 mm Hg | Standard Error 0.66 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -16.16 mm Hg | Standard Error 0.66 |
p-value: 0.01195% CI: [-4.14, -0.53]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -5.35 mm Hg | Standard Error 0.62 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -16.16 mm Hg | Standard Error 0.66 |
p-value: <0.00195% CI: [-12.57, -9.05]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -7.99 mm Hg | Standard Error 0.63 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -13.98 mm Hg | Standard Error 0.66 |
p-value: <0.00195% CI: [-7.77, -4.22]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -11.0 mm Hg | Standard Error 0.65 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -13.98 mm Hg | Standard Error 0.66 |
p-value: 0.00195% CI: [-4.77, -1.19]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -5.35 mm Hg | Standard Error 0.62 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -13.98 mm Hg | Standard Error 0.66 |
p-value: <0.00195% CI: [-10.39, -6.87]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -10.19 mm Hg | Standard Error 0.62 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -16.45 mm Hg | Standard Error 0.65 |
p-value: <0.00195% CI: [-8, -4.51]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -13.82 mm Hg | Standard Error 0.66 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -16.45 mm Hg | Standard Error 0.65 |
p-value: 0.00495% CI: [-4.42, -0.83]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -5.35 mm Hg | Standard Error 0.62 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -16.45 mm Hg | Standard Error 0.65 |
p-value: <0.00195% CI: [-12.85, -9.35]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -10.19 mm Hg | Standard Error 0.62 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -14.99 mm Hg | Standard Error 0.66 |
p-value: <0.00195% CI: [-6.56, -3.03]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -11.0 mm Hg | Standard Error 0.65 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -14.99 mm Hg | Standard Error 0.66 |
p-value: <0.00195% CI: [-5.78, -2.18]ANCOVA
Primary
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -5.35 mm Hg | Standard Error 0.62 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | -14.99 mm Hg | Standard Error 0.66 |
p-value: <0.00195% CI: [-11.41, -7.87]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP) | -10.67 mm Hg | Standard Error 1.01 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP) | -23.87 mm Hg | Standard Error 1.05 |
p-value: <0.00195% CI: [-16.04, -10.4]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All randomized patients who received the study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -21.04 mm Hg | Standard Error 1.05 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -23.87 mm Hg | Standard Error 1.05 |
p-value: 0.05695% CI: [-5.73, -0.07]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -6.79 mm Hg | Standard Error 1 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -23.87 mm Hg | Standard Error 1.05 |
p-value: <0.00195% CI: [-19.91, -14.3]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -10.67 mm Hg | Standard Error 1.01 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -20.64 mm Hg | Standard Error 1.05 |
p-value: <0.00195% CI: [-12.81, -7.12]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -15.82 mm Hg | Standard Error 1.04 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -20.64 mm Hg | Standard Error 1.05 |
p-value: 0.00195% CI: [-7.7, -1.94]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -6.79 mm Hg | Standard Error 1 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -20.64 mm Hg | Standard Error 1.05 |
p-value: <0.00195% CI: [-16.68, -11]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -15.37 mm Hg | Standard Error 0.99 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -23.19 mm Hg | Standard Error 1.04 |
p-value: <0.00195% CI: [-10.63, -5.02]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -21.04 mm Hg | Standard Error 1.05 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -23.19 mm Hg | Standard Error 1.04 |
p-value: 0.14395% CI: [-5.04, 0.73]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -6.79 mm Hg | Standard Error 1 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -23.19 mm Hg | Standard Error 1.04 |
p-value: <0.00195% CI: [-19.21, -13.6]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -15.37 mm Hg | Standard Error 0.99 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -21.82 mm Hg | Standard Error 1.06 |
p-value: <0.00195% CI: [-9.29, -3.62]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -15.82 mm Hg | Standard Error 1.04 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -21.82 mm Hg | Standard Error 1.06 |
p-value: <0.00195% CI: [-8.9, -3.11]ANCOVA
Secondary
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: Baseline to end of study (Week 8)
Population: Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 150 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -6.79 mm Hg | Standard Error 1 |
| Aliskiren/Amlodipine 150/5 mg | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | -21.82 mm Hg | Standard Error 1.06 |
p-value: <0.00195% CI: [-17.88, -12.2]ANCOVA
Secondary
Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response
Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure \< 90 mmHg or a \>=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: End of study (Week 8)
Population: All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aliskiren 150 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 34.3 Percentage of Participants |
| Aliskiren/Amlodipine 150/5 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 50.3 Percentage of Participants |
| Aliskiren 300 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 54.2 Percentage of Participants |
| Amlodipine 5 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 62.0 Percentage of Participants |
| Amlodipine 10 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 74.3 Percentage of Participants |
| Aliskiren/Amlodipine 150/5 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 73.2 Percentage of Participants |
| Aliskiren/Amlodipine 150/10 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 83.8 Percentage of Participants |
| Aliskiren/Amlodipine 300/5 mg | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 73.7 Percentage of Participants |
| Aliskiren/Amlodipine 300/10 mg Tablet | Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response | 84.7 Percentage of Participants |
Secondary
Percentage of Patients Achieving a Successful Systolic Blood Pressure Response
Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure \< 140 mmHg or a \>= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: End of study (Week 8)
Population: All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aliskiren 150 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 32.3 Percentage of Participants |
| Aliskiren/Amlodipine 150/5 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 41.5 Percentage of Participants |
| Aliskiren 300 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 53.2 Percentage of Participants |
| Amlodipine 5 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 54.9 Percentage of Participants |
| Amlodipine 10 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 72.1 Percentage of Participants |
| Aliskiren/Amlodipine 150/5 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 67.6 Percentage of Participants |
| Aliskiren/Amlodipine 150/10 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 77.1 Percentage of Participants |
| Aliskiren/Amlodipine 300/5 mg | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 69.7 Percentage of Participants |
| Aliskiren/Amlodipine 300/10 mg Tablet | Percentage of Patients Achieving a Successful Systolic Blood Pressure Response | 80.3 Percentage of Participants |
Secondary
Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study
Blood pressure control defined as msSBP \< 140 mm Hg and msDBP \< 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time frame: End of study (Week 8)
Population: All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aliskiren 150 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 19.2 Percentage of Participants |
| Aliskiren/Amlodipine 150/5 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 26.9 Percentage of Participants |
| Aliskiren 300 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 36.3 Percentage of Participants |
| Amlodipine 5 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 35.9 Percentage of Participants |
| Amlodipine 10 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 50.3 Percentage of Participants |
| Aliskiren/Amlodipine 150/5 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 49.2 Percentage of Participants |
| Aliskiren/Amlodipine 150/10 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 65.4 Percentage of Participants |
| Aliskiren/Amlodipine 300/5 mg | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 56.5 Percentage of Participants |
| Aliskiren/Amlodipine 300/10 mg Tablet | Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study | 68.3 Percentage of Participants |