Trial Outcomes & Findings for Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension (NCT NCT00797862)
NCT ID: NCT00797862
Last Updated: 2011-10-17
Results Overview
Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1254 participants
Primary outcome timeframe
Baseline, 8 weeks, 16 weeks, and 24 weeks
Results posted on
2011-10-17
Participant Flow
A 2-4 week single-blind placebo run in. 7 patients were assigned a randomization number in error (3 each in the aliskiren/amlodipine initial treatment and aliskiren based add-on regimens and 1 in the amlodipine based add-on regimen). These patients did not take any double-blind study medication and were excluded from the Full Analysis Set (FAS).
Participant milestones
| Measure |
Aliskiren+Amlodipine
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
620
|
318
|
316
|
|
Overall Study
Entered Double-Blind Treatment (FAS)
|
617
|
315
|
315
|
|
Overall Study
COMPLETED
|
496
|
250
|
230
|
|
Overall Study
NOT COMPLETED
|
124
|
68
|
86
|
Reasons for withdrawal
| Measure |
Aliskiren+Amlodipine
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
86
|
44
|
58
|
|
Overall Study
Abnormal Test Procedure Result
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
7
|
6
|
|
Overall Study
No longer required study medication
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
7
|
7
|
|
Overall Study
Lost to Follow-up
|
11
|
0
|
5
|
|
Overall Study
Administrative Problem
|
4
|
0
|
0
|
|
Overall Study
Protocol Violation
|
4
|
6
|
8
|
|
Overall Study
Mis-randomized
|
3
|
3
|
1
|
Baseline Characteristics
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren+Amlodipine
n=620 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=318 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=316 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Total
n=1254 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
58.1 years
STANDARD_DEVIATION 10.81 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 10.84 • n=4 Participants
|
|
Sex: Female, Male
Female
|
305 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
619 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
315 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
635 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.
Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Outcome measures
| Measure |
Aliskiren+Amlodipine
n=604 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=312 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=313 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks
|
-25.34 mmHg
Standard Error 0.436
|
-17.94 mmHg
Standard Error 0.600
|
-19.81 mmHg
Standard Error 0.611
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.
Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Outcome measures
| Measure |
Aliskiren+Amlodipine
n=604 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=312 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=313 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24
|
-27.37 mmHg
Standard Error 0.546
|
-26.34 mmHg
Standard Error 0.738
|
-25.52 mmHg
Standard Error 0.782
|
SECONDARY outcome
Timeframe: Baseline to 32 weeksPopulation: The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.
Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.
Outcome measures
| Measure |
Aliskiren+Amlodipine
n=604 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=312 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=313 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32
|
-12.96 mmHg
Standard Error 0.323
|
-12.96 mmHg
Standard Error 0.446
|
-11.62 mmHg
Standard Error 0.467
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 16 weeks and 24 weeksPopulation: The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.
Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.
Outcome measures
| Measure |
Aliskiren+Amlodipine
n=604 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=312 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=313 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks
|
-12.39 mmHg
Standard Error 0.247
|
-8.37 mmHg
Standard Error 0.340
|
-9.02 mmHg
Standard Error 0.347
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.
Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.
Outcome measures
| Measure |
Aliskiren+Amlodipine
n=604 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=312 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=313 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24
|
-13.64 mmHg
Standard Error 0.319
|
-13.22 mmHg
Standard Error 0.431
|
-12.25 mmHg
Standard Error 0.457
|
SECONDARY outcome
Timeframe: Baseline to week 8, 16, 24 and 32 endpointsPopulation: The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure. Last post-baseline observation was carried forward to each visit for the analysis of blood pressure control.
Systolic \& Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP \<140 mmHg and msDBP \<90 mmHg) at weeks 8, 16, 24 \& 32 endpoints.
Outcome measures
| Measure |
Aliskiren+Amlodipine
n=604 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=312 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=313 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
Week 8 endpoint
|
46.5 Percentage of Participants
0.566
|
22.8 Percentage of Participants
0.781
|
25.2 Percentage of Participants
0.816
|
|
Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
Week 16 endpoint
|
65.9 Percentage of Participants
|
33.3 Percentage of Participants
|
40.9 Percentage of Participants
|
|
Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
Week 24 endpoint
|
63.4 Percentage of Participants
|
62.8 Percentage of Participants
|
57.8 Percentage of Participants
|
|
Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
Week 32 endpoint
|
61.6 Percentage of Participants
|
59.0 Percentage of Participants
|
53.4 Percentage of Participants
|
POST_HOC outcome
Timeframe: Baseline to 32 weeksPopulation: The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.
Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 \& 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msSBP was a covariate.
Outcome measures
| Measure |
Aliskiren+Amlodipine
n=604 Participants
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren Start-Amlodipine Add On
n=312 Participants
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine Start-Aliskiren Add On
n=313 Participants
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32
|
-26.42 mmHg
Standard Error 0.566
|
-25.75 mmHg
Standard Error 0.781
|
-24.32 mmHg
Standard Error 0.816
|
Adverse Events
Aliskiren + Amlodipine
Serious events: 14 serious events
Other events: 196 other events
Deaths: 0 deaths
Aliskiren
Serious events: 9 serious events
Other events: 81 other events
Deaths: 0 deaths
Amlodipine
Serious events: 9 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren + Amlodipine
n=617 participants at risk
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren
n=315 participants at risk
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine
n=315 participants at risk
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.16%
1/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/617
|
0.32%
1/315
|
0.32%
1/315
|
|
Renal and urinary disorders
Haematuria
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Renal and urinary disorders
Renal colic
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Cardiac disorders
Cardiac failure congestive
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/617
|
0.00%
0/315
|
0.32%
1/315
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
General disorders
Chest pain
|
0.00%
0/617
|
0.32%
1/315
|
0.00%
0/315
|
|
General disorders
Oedema peripheral
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.16%
1/617
|
0.00%
0/315
|
0.00%
0/315
|
Other adverse events
| Measure |
Aliskiren + Amlodipine
n=617 participants at risk
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Aliskiren
n=315 participants at risk
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
Amlodipine
n=315 participants at risk
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
21.2%
131/617
|
16.8%
53/315
|
24.1%
76/315
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.5%
46/617
|
6.3%
20/315
|
6.7%
21/315
|
|
Nervous system disorders
Headache
|
5.0%
31/617
|
6.3%
20/315
|
5.1%
16/315
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862- 778- 8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with it's investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until publication of pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER