Trial Outcomes & Findings for Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension (NCT NCT00219141)
NCT ID: NCT00219141
Last Updated: 2011-05-26
Results Overview
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
460 participants
Primary outcome timeframe
Baseline to end of study (Week 36)
Results posted on
2011-05-26
Participant Flow
Participant milestones
| Measure |
Aliskiren 300 mg
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
154
|
152
|
154
|
|
Overall Study
COMPLETED
|
140
|
131
|
142
|
|
Overall Study
NOT COMPLETED
|
14
|
21
|
12
|
Reasons for withdrawal
| Measure |
Aliskiren 300 mg
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
10
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
0
|
|
Overall Study
Administrative problems
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
5
|
|
Overall Study
Condition no longer requires study drug
|
1
|
0
|
0
|
Baseline Characteristics
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren 300 mg
n=154 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=152 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=154 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
58.4 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 11.00 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 10.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
348 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=136 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)
|
-5.51 g/m^2
Standard Error 0.95
|
-4.81 g/m^2
Standard Error 0.98
|
-5.61 g/m^2
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=136 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)
|
-4.87 g/m^2
Standard Deviation 11.69
|
-4.79 g/m^2
Standard Deviation 11.87
|
-5.81 g/m^2
Standard Deviation 10.93
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=134 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
|
-7.05 mL
Standard Deviation 24.09
|
-4.52 mL
Standard Deviation 25.15
|
-7.03 mL
Standard Deviation 24.97
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=134 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
|
-3.20 mL
Standard Deviation 16.64
|
-4.73 mL
Standard Deviation 15.16
|
-5.14 mL
Standard Deviation 15.35
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=134 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
|
-0.95 mm
Standard Deviation 2.71
|
-1.20 mm
Standard Deviation 2.56
|
-1.17 mm
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=134 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
|
-0.88 mm
Standard Deviation 2.03
|
-0.89 mm
Standard Deviation 2.16
|
-0.90 mm
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=133 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=129 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=137 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)
|
-0.71 mm
Standard Deviation 1.72
|
-0.64 mm
Standard Deviation 2.16
|
-0.86 mm
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=134 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)
|
-9.81 g
Standard Deviation 23.84
|
-9.92 g
Standard Deviation 24.24
|
-12.29 g
Standard Deviation 22.58
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=133 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)
|
0.62 percent
Standard Deviation 7.73
|
2.02 percent
Standard Deviation 6.70
|
1.92 percent
Standard Deviation 7.00
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.
Outcome measures
| Measure |
Aliskiren 300 mg
n=132 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=123 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=133 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)
|
-3.89 mL
Standard Deviation 17.83
|
0.24 mL
Standard Deviation 17.53
|
-2.24 mL
Standard Deviation 17.25
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.
Outcome measures
| Measure |
Aliskiren 300 mg
n=145 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=146 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=146 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
|
-1.07 mm
Standard Deviation 3.78
|
-0.97 mm
Standard Deviation 4.22
|
-1.43 mm
Standard Deviation 3.81
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 36)Population: Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.
Outcome measures
| Measure |
Aliskiren 300 mg
n=140 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=144 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=146 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
|
-104.97 mm * ms
Standard Deviation 376.30
|
-150.31 mm * ms
Standard Deviation 439.81
|
-130.65 mm * ms
Standard Deviation 453.17
|
SECONDARY outcome
Timeframe: Baseline the end of study (Week 36)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. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.
Outcome measures
| Measure |
Aliskiren 300 mg
n=83 Participants
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=89 Participants
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=84 Participants
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)
Systolic
|
-2.67 mm Hg
Standard Error 1.19
|
-3.81 mm Hg
Standard Error 1.17
|
-6.97 mm Hg
Standard Error 1.21
|
|
Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)
Diastolic
|
-1.31 mm Hg
Standard Error 0.82
|
-1.92 mm Hg
Standard Error 0.81
|
-4.11 mm Hg
Standard Error 0.83
|
Adverse Events
Aliskiren 300 mg
Serious events: 10 serious events
Other events: 31 other events
Deaths: 0 deaths
Losartan 100 mg
Serious events: 13 serious events
Other events: 31 other events
Deaths: 0 deaths
Aliskiren/Losartan 300/100 mg
Serious events: 10 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren 300 mg
n=154 participants at risk
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=152 participants at risk
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=154 participants at risk
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Cardiac disorders
Angina pectoris
|
0.65%
1/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
2/154
|
1.3%
2/152
|
0.65%
1/154
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Cardiac disorders
Palpitations
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Cardiac disorders
Sick sinus syndrome
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Infections and infestations
Bronchitis
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Infections and infestations
Diverticulitis
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Infections and infestations
Erysipelas
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Infections and infestations
Otitis media
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Infections and infestations
Pneumonia
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Infections and infestations
Sepsis
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Infections and infestations
Sinusitis
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Head injury
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Nervous system disorders
Neuropathy
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Psychiatric disorders
Depression
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.65%
1/154
|
0.00%
0/152
|
0.00%
0/154
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
|
Vascular disorders
Haematoma
|
0.00%
0/154
|
0.66%
1/152
|
0.00%
0/154
|
|
Vascular disorders
Thrombosis
|
0.00%
0/154
|
0.00%
0/152
|
0.65%
1/154
|
Other adverse events
| Measure |
Aliskiren 300 mg
n=154 participants at risk
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
|
Losartan 100 mg
n=152 participants at risk
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
|
Aliskiren/Losartan 300/100 mg
n=154 participants at risk
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
6/154
|
5.9%
9/152
|
4.5%
7/154
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
11/154
|
8.6%
13/152
|
7.1%
11/154
|
|
Nervous system disorders
Dizziness
|
3.2%
5/154
|
2.0%
3/152
|
5.2%
8/154
|
|
Nervous system disorders
Headache
|
9.1%
14/154
|
5.3%
8/152
|
6.5%
10/154
|
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