Trial Outcomes & Findings for Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension. (NCT NCT00654875)
NCT ID: NCT00654875
Last Updated: 2011-06-28
Results Overview
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.
COMPLETED
PHASE4
328 participants
Baseline, Week 6
2011-06-28
Participant Flow
Participant milestones
| Measure |
Aliskiren 300 mg (Once a Day)
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
164
|
|
Overall Study
COMPLETED
|
147
|
147
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
Aliskiren 300 mg (Once a Day)
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Abnormal Test Procedure Result(s)
|
1
|
0
|
|
Overall Study
Administrative Problems
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.
Baseline characteristics by cohort
| Measure |
Aliskiren 300 mg (Once a Day)
n=164 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=164 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
54 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
54 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.
Outcome measures
| Measure |
Aliskiren 300 mg (Once a Day)
n=139 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=127 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)
|
-4.10 mm Hg
Standard Error 0.60
|
-5.24 mm Hg
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.
Outcome measures
| Measure |
Aliskiren 300 mg (Once a Day)
n=136 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=121 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period
|
-5.03 mm Hg
Standard Error 0.77
|
-5.24 mm Hg
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.
Outcome measures
| Measure |
Aliskiren 300 mg (Once a Day)
n=136 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=121 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period
|
-6.39 mm Hg
Standard Error 1.04
|
-7.12 mm Hg
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.
Outcome measures
| Measure |
Aliskiren 300 mg (Once a Day)
n=139 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=127 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)
|
-5.74 mm Hg
Standard Error 0.87
|
-7.44 mm Hg
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate.
Outcome measures
| Measure |
Aliskiren 300 mg (Once a Day)
n=158 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=156 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure
Diastolic Blood Pressure
|
-10.30 mm Hg
Standard Error 0.66
|
-10.57 mm Hg
Standard Error 0.67
|
|
Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure
Systolic Blood Pressure
|
-11.72 mm Hg
Standard Error 1.11
|
-13.10 mm Hg
Standard Error 1.11
|
SECONDARY outcome
Timeframe: Week 6Population: Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 6.
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) \<90 mm Hg and a mean sitting systolic blood pressure (msSBP) \<140 mm Hg.
Outcome measures
| Measure |
Aliskiren 300 mg (Once a Day)
n=158 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=156 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Percentage of Participants Achieving Blood Pressure Control at Week 6
|
24.7 Percentage of participants
|
26.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 10Population: Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 10.
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) \<90 mm Hg and a mean sitting systolic blood pressure (msSBP) \<140 mm Hg.
Outcome measures
| Measure |
Aliskiren 300 mg (Once a Day)
n=154 Participants
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=155 Participants
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)
|
24.0 Percentage of participants
|
27.7 Percentage of participants
|
Adverse Events
Aliskiren 300 mg (Once a Day)
Aliskiren 150 mg (Twice a Day)
Serious adverse events
| Measure |
Aliskiren 300 mg (Once a Day)
n=164 participants at risk
Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
|
Aliskiren 150 mg (Twice a Day)
n=164 participants at risk
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.61%
1/164 • 10 Weeks
|
0.00%
0/164 • 10 Weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/164 • 10 Weeks
|
0.61%
1/164 • 10 Weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/164 • 10 Weeks
|
0.61%
1/164 • 10 Weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/164 • 10 Weeks
|
0.61%
1/164 • 10 Weeks
|
|
Nervous system disorders
Syncope
|
0.61%
1/164 • 10 Weeks
|
0.00%
0/164 • 10 Weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER