Trial Outcomes & Findings for Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study (NCT NCT00706134)
NCT ID: NCT00706134
Last Updated: 2011-06-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
756 participants
Primary outcome timeframe
Baseline to end of study (Week 8)
Results posted on
2011-06-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
189
|
192
|
189
|
186
|
|
Overall Study
Entered Double-blind Period
|
187
|
192
|
189
|
186
|
|
Overall Study
COMPLETED
|
169
|
173
|
183
|
175
|
|
Overall Study
NOT COMPLETED
|
20
|
19
|
6
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
6
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
9
|
3
|
3
|
5
|
|
Overall Study
Did not meet study criteria
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
Baseline characteristics by cohort
| Measure |
Placebo
n=189 Participants
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=192 Participants
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=189 Participants
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=186 Participants
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
Total
n=756 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
≥ 65 and < 75 years of age
|
128 Participants
n=93 Participants
|
131 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
129 Participants
n=483 Participants
|
517 Participants
n=36 Participants
|
|
Age, Customized
≥ 75 years of age
|
61 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
239 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
102 Participants
n=483 Participants
|
417 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
84 Participants
n=483 Participants
|
339 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=192 Participants
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=188 Participants
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=186 Participants
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
|
-7.97 mmHg
Standard Error 1.043
|
-12.51 mmHg
Standard Error 1.024
|
-15.28 mmHg
Standard Error 1.035
|
-14.14 mmHg
Standard Error 1.042
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=192 Participants
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=188 Participants
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=186 Participants
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
|
-3.50 mmHg
Standard Error 0.579
|
-5.33 mmHg
Standard Error 0.568
|
-6.42 mmHg
Standard Error 0.575
|
-6.66 mmHg
Standard Error 0.579
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.
Patients achieving a systolic blood pressure response had to have a msSBP \< 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=192 Participants
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=188 Participants
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=186 Participants
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Percentage of Patients Achieving Systolic Blood Pressure Response
|
28.8 Percentage of participants
|
42.4 Percentage of participants
|
44.1 Percentage of participants
|
47.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.
Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=64 Participants
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=70 Participants
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=58 Participants
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study
Ambulatory Systolic Blood Pressure
|
-1.15 mmHg
Standard Error 1.280
|
-3.33 mmHg
Standard Error 1.155
|
-5.76 mmHg
Standard Error 1.128
|
-5.83 mmHg
Standard Error 1.520
|
|
Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study
Ambulatory Diastolic Blood Pressure
|
0.31 mmHg
Standard Error 0.990
|
-1.78 mmHg
Standard Error 0.877
|
-3.26 mmHg
Standard Error 0.693
|
-2.45 mmHg
Standard Error 0.823
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.
Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=64 Participants
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=70 Participants
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=58 Participants
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
|
-0.11 Ratio
Standard Error 0.102
|
-0.38 Ratio
Standard Error 0.092
|
-0.50 Ratio
Standard Error 0.089
|
-0.51 Ratio
Standard Error 0.096
|
SECONDARY outcome
Timeframe: Baseline to end of study (week 8)Population: Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.
The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=64 Participants
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=70 Participants
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=58 Participants
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
|
0.46 mmHg
Standard Error 1.782
|
-3.04 mmHg
Standard Error 1.596
|
-7.03 mmHg
Standard Error 1.539
|
-3.96 mmHg
Standard Error 1.660
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Aliskiren 75 mg
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Aliskiren 150 mg
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Aliskiren 300 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=186 participants at risk
Placebo tablet taken once daily in the morning with a light meal.
|
Aliskiren 75 mg
n=191 participants at risk
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 150 mg
n=189 participants at risk
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
Aliskiren 300 mg
n=188 participants at risk
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.54%
1/186 • End of study (week 8)
Population description of safety set.
|
0.00%
0/191 • End of study (week 8)
Population description of safety set.
|
0.00%
0/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Eye disorders
Glaucoma
|
0.00%
0/186 • End of study (week 8)
Population description of safety set.
|
0.00%
0/191 • End of study (week 8)
Population description of safety set.
|
0.53%
1/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/186 • End of study (week 8)
Population description of safety set.
|
0.00%
0/191 • End of study (week 8)
Population description of safety set.
|
0.53%
1/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/186 • End of study (week 8)
Population description of safety set.
|
0.52%
1/191 • End of study (week 8)
Population description of safety set.
|
0.00%
0/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.54%
1/186 • End of study (week 8)
Population description of safety set.
|
0.00%
0/191 • End of study (week 8)
Population description of safety set.
|
0.00%
0/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.54%
1/186 • End of study (week 8)
Population description of safety set.
|
0.00%
0/191 • End of study (week 8)
Population description of safety set.
|
0.00%
0/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.54%
1/186 • End of study (week 8)
Population description of safety set.
|
0.00%
0/191 • End of study (week 8)
Population description of safety set.
|
0.00%
0/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/186 • End of study (week 8)
Population description of safety set.
|
0.52%
1/191 • End of study (week 8)
Population description of safety set.
|
0.00%
0/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/186 • End of study (week 8)
Population description of safety set.
|
0.00%
0/191 • End of study (week 8)
Population description of safety set.
|
0.53%
1/189 • End of study (week 8)
Population description of safety set.
|
0.00%
0/188 • End of study (week 8)
Population description of safety set.
|
Other adverse events
Adverse event data not reported
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 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