Hypertension, Left Ventricular Hypertrophy, Overweight
Conditions
Brief summary
To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.
Interventions
DRUGAliskiren placebo
Aliskiren 150 mg placebo tablet
DRUGLosartan 50/100 mg placebo
Losartan 50/100 mg placebo capsules
DRUGAliskiren 150/300 mg
Aliskiren 150 mg tablets
DRUGLosartan 50/100 mg
Losartan 50 or 100 mg capsules
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with essential hypertension * Patients with a BMI \> 25 kg/m2 * Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO
Exclusion criteria
* Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo the 3 month washout period. * Patients treated with an ACE and ARB combination at study entry. * Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis). Other protocol related inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline to end of study (Week 36) | — |
| 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) | Baseline to end of study (Week 36) | — |
| 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) | Baseline to end of study (Week 36) | — |
| 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) | Baseline to end of study (Week 36) | — |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | — |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | — |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | — |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | — |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | — |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | — |
| Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36) | Baseline the end of study (Week 36) | 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. |
| 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) | Baseline to end of study (Week 36) | — |
Countries
Argentina, Colombia, Finland, Germany, Italy, Russia, Spain, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 154 |
| 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. | 152 |
| 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. | 154 |
| Total | 460 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems | 0 | 1 | 0 |
| Overall Study | Adverse Event | 4 | 10 | 5 |
| Overall Study | Condition no longer requires study drug | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 3 | 2 | 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 |
Baseline characteristics
| Characteristic | Aliskiren 300 mg | Losartan 100 mg | Aliskiren/Losartan 300/100 mg | Total |
|---|---|---|---|---|
| Age Continuous | 58.4 years STANDARD_DEVIATION 9.61 | 59.2 years STANDARD_DEVIATION 11 | 58.8 years STANDARD_DEVIATION 10.62 | 58.8 years STANDARD_DEVIATION 10.41 |
| Sex: Female, Male Female | 42 Participants | 35 Participants | 35 Participants | 112 Participants |
| Sex: Female, Male Male | 112 Participants | 117 Participants | 119 Participants | 348 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 154 | 31 / 152 | 29 / 154 |
| serious Total, serious adverse events | 10 / 154 | 13 / 152 | 10 / 154 |
Outcome results
Primary
Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | -5.51 g/m^2 | Standard Error 0.95 |
| Losartan 100 mg | Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | -4.81 g/m^2 | Standard Error 0.98 |
| Aliskiren/Losartan 300/100 mg | Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | -5.61 g/m^2 | Standard Error 0.93 |
Secondary
Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36) | Systolic | -3.81 mm Hg | Standard Error 1.17 |
| Losartan 100 mg | Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36) | Diastolic | -1.92 mm Hg | Standard Error 0.81 |
| Aliskiren/Losartan 300/100 mg | Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36) | Systolic | -6.97 mm Hg | Standard Error 1.21 |
| Aliskiren/Losartan 300/100 mg | Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36) | Diastolic | -4.11 mm Hg | Standard Error 0.83 |
Secondary
Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 376.3 |
| Losartan 100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | -150.31 mm * ms | Standard Deviation 439.81 |
| Aliskiren/Losartan 300/100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | -130.65 mm * ms | Standard Deviation 453.17 |
Secondary
Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) | -0.64 mm | Standard Deviation 2.16 |
| Aliskiren/Losartan 300/100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) | -0.86 mm | Standard Deviation 2.06 |
Secondary
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | 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) | -1.20 mm | Standard Deviation 2.56 |
| Aliskiren/Losartan 300/100 mg | 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) | -1.17 mm | Standard Deviation 2.61 |
Secondary
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) | 2.02 percent | Standard Deviation 6.7 |
| Aliskiren/Losartan 300/100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) | 1.92 percent | Standard Deviation 7 |
Secondary
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | 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) | -9.92 g | Standard Deviation 24.24 |
| Aliskiren/Losartan 300/100 mg | 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) | -12.29 g | Standard Deviation 22.58 |
Secondary
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | 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) | -4.52 mL | Standard Deviation 25.15 |
| Aliskiren/Losartan 300/100 mg | 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) | -7.03 mL | Standard Deviation 24.97 |
Secondary
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | 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) | -4.73 mL | Standard Deviation 15.16 |
| Aliskiren/Losartan 300/100 mg | 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) | -5.14 mL | Standard Deviation 15.35 |
Secondary
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | 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) | -0.89 mm | Standard Deviation 2.16 |
| Aliskiren/Losartan 300/100 mg | 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) | -0.90 mm | Standard Deviation 2.22 |
Secondary
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | -4.79 g/m^2 | Standard Deviation 11.87 |
| Aliskiren/Losartan 300/100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | -5.81 g/m^2 | Standard Deviation 10.93 |
Secondary
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) | 0.24 mL | Standard Deviation 17.53 |
| Aliskiren/Losartan 300/100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) | -2.24 mL | Standard Deviation 17.25 |
Secondary
Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren 300 mg | 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 |
| Losartan 100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | -0.97 mm | Standard Deviation 4.22 |
| Aliskiren/Losartan 300/100 mg | Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | -1.43 mm | Standard Deviation 3.81 |