Hypertension, Left Ventricle Hypertrophy
Conditions
Keywords
Aliskiren, hypertension, concentric LVH, LV remodeling, LVMI, biomarkers, PICP, CT-1, MMP-1, TIMP-1, AnxA5, Aldosterone, Essential hypertension with concentric left ventricle hypertrophy
Brief summary
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.
Detailed description
Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (\<140/90 mmHg). The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (\<140/90 mmHg), the dose of amlodipine was increased to 10 mg. Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (\<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed
Interventions
DRUGAliskiren
Aliskiren 300 mg film coated tablets
DRUGLosartan
Losartan 100 mg tablets
DRUGAmlodipine
Amlodipine 5mg was given to patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (\<140/90 mmHg) was still not achieved.
HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (\<140/90 mmHg) had not been reached.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient with hypertension * Confirmed concentric left ventricular hypertrophy: * LVMI \> 49.2 g/m2.7 for men and \>46.7 g/m2.7 for women * Relative wall thickness \> 0.42
Exclusion criteria
* Sever or secondary HTN * LV ejection fraction of \<40% * Patient with compelling indication to ACEIs or ARBs or BB * History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry * History of collagenopathies, osteopathy * eGFR \<30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L * Morbid obesity (BMI ≥ 42 kg/m2 * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP) | Baseline, Week 36 | PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease | Baseline, Week 36 | The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI) |
| Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule |
| Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson) |
| Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter |
| Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method) |
| Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI) | Baseline, Week 36 | Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI |
| Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | Baseline, Week 36 | The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) |
| Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine | Baseline, Week 36 | The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). |
| Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule |
| Change From Baseline in Biomarkers in Heart Disease | Baseline, Week 36 | The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) |
| Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter |
| Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method) |
| Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine | Baseline, Week 36 | Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI |
| Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 10,18,26,36 | The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values |
| Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 10,18,26,36 | The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values |
| Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week10,18,26,36 | Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP \< 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP \< 90 mmHg or reduction of ≥ 5 mmHg compared to baseline) |
| Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Week10,18,26,36 | The control rate was defined as the proportion of patients with SBP \< 140 mmHg and DBP \< 90 mmHg compared to baseline |
| Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs | Baseline, Week 10,18,26 | The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide |
| Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | Baseline, Week 36 | Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks | 32 |
| Lostaran Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks | 37 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Informed consent withdrawn | 3 | 0 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Unsatisfactory therapeutic effect | 0 | 1 |
Baseline characteristics
| Characteristic | Aliskiren | Lostaran | Total |
|---|---|---|---|
| Age, Continuous | 60.34 Years STANDARD_DEVIATION 9.34 | 58.05 Years STANDARD_DEVIATION 10.34 | 59.12 Years STANDARD_DEVIATION 9.88 |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 23 Participants | 26 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 37 | 16 / 37 |
| serious Total, serious adverse events | 2 / 37 | 0 / 37 |
Outcome results
Primary
Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP) | -5.22 ug/l | Standard Deviation 20.37 |
| Lostaran | Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP) | -4.25 ug/l | Standard Deviation 24.8 |
Secondary
Change From Baseline in Biomarkers in Heart Disease
The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Change From Baseline in Biomarkers in Heart Disease | tissue inhibitor of MMPs (TIMP-1) (n=32,37) | -0.70 ng/ml | Standard Deviation 59.18 |
| Aliskiren | Change From Baseline in Biomarkers in Heart Disease | NT-proBNP (n=31,34) | 18.66 ng/ml | Standard Deviation 165.21 |
| Aliskiren | Change From Baseline in Biomarkers in Heart Disease | cardiotrophin-1 (CT-1) (n=32,37) | -169.15 ng/ml | Standard Deviation 561.51 |
| Aliskiren | Change From Baseline in Biomarkers in Heart Disease | matrix metalloproteinase-1 (MMP-1) (n=32,37) | 5.93 ng/ml | Standard Deviation 13.33 |
| Aliskiren | Change From Baseline in Biomarkers in Heart Disease | annexin A5 (AnxA5) (n=31,37) | -0.98 ng/ml | Standard Deviation 7.33 |
| Lostaran | Change From Baseline in Biomarkers in Heart Disease | annexin A5 (AnxA5) (n=31,37) | -1.21 ng/ml | Standard Deviation 4.75 |
| Lostaran | Change From Baseline in Biomarkers in Heart Disease | tissue inhibitor of MMPs (TIMP-1) (n=32,37) | 9.15 ng/ml | Standard Deviation 42.58 |
| Lostaran | Change From Baseline in Biomarkers in Heart Disease | matrix metalloproteinase-1 (MMP-1) (n=32,37) | 5.51 ng/ml | Standard Deviation 9.58 |
| Lostaran | Change From Baseline in Biomarkers in Heart Disease | NT-proBNP (n=31,34) | -7.55 ng/ml | Standard Deviation 38.11 |
| Lostaran | Change From Baseline in Biomarkers in Heart Disease | cardiotrophin-1 (CT-1) (n=32,37) | -128.23 ng/ml | Standard Deviation 568.02 |
Secondary
Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease
The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease | -1.81 ng/dl | Standard Deviation 27.78 |
| Lostaran | Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease | -7.90 ng/dl | Standard Deviation 76.35 |
Secondary
Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine
The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine | 2.81 ng/dl | Standard Deviation 21.36 |
| Lostaran | Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine | -5.89 ng/dl | Standard Deviation 32.54 |
| Losartan | Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine | -3.12 ng/dl | Standard Deviation 32.45 |
| Losartan + Amlodipine | Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine | -11.55 ng/dl | Standard Deviation 98.35 |
Secondary
Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.
The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | TIMP-1 (n=15,17,16,21) | -10.01 ng/ml | Standard Deviation 73 |
| Aliskiren | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | NT-proBNP (n=15,16,15,19) | 21.00 ng/ml | Standard Deviation 214.06 |
| Aliskiren | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | CT-1(n=15,17,16,21) | -289.18 ng/ml | Standard Deviation 608.91 |
| Aliskiren | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | MMP-1(n=15,17,16,21) | 7.00 ng/ml | Standard Deviation 10.28 |
| Aliskiren | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | ANXA5 (n=15,16,16,21) | -1.24 ng/ml | Standard Deviation 3.7 |
| Lostaran | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | TIMP-1 (n=15,17,16,21) | 7.51 ng/ml | Standard Deviation 44.38 |
| Lostaran | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | MMP-1(n=15,17,16,21) | 4.99 ng/ml | Standard Deviation 15.8 |
| Lostaran | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | NT-proBNP (n=15,16,15,19) | 16.46 ng/ml | Standard Deviation 108.69 |
| Lostaran | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | ANXA5 (n=15,16,16,21) | -0.74 ng/ml | Standard Deviation 9.73 |
| Lostaran | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | CT-1(n=15,17,16,21) | -63.23 ng/ml | Standard Deviation 510.91 |
| Losartan | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | MMP-1(n=15,17,16,21) | 5.47 ng/ml | Standard Deviation 7.88 |
| Losartan | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | CT-1(n=15,17,16,21) | 156.89 ng/ml | Standard Deviation 599.29 |
| Losartan | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | TIMP-1 (n=15,17,16,21) | 21.38 ng/ml | Standard Deviation 38.4 |
| Losartan | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | ANXA5 (n=15,16,16,21) | -1.73 ng/ml | Standard Deviation 4.21 |
| Losartan | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | NT-proBNP (n=15,16,15,19) | -3.68 ng/ml | Standard Deviation 23.78 |
| Losartan + Amlodipine | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | NT-proBNP (n=15,16,15,19) | -10.60 ng/ml | Standard Deviation 46.91 |
| Losartan + Amlodipine | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | CT-1(n=15,17,16,21) | -345.47 ng/ml | Standard Deviation 443.63 |
| Losartan + Amlodipine | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | MMP-1(n=15,17,16,21) | 5.54 ng/ml | Standard Deviation 10.89 |
| Losartan + Amlodipine | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | TIMP-1 (n=15,17,16,21) | -0.16 ng/ml | Standard Deviation 44.13 |
| Losartan + Amlodipine | Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease. | ANXA5 (n=15,16,16,21) | -0.81 ng/ml | Standard Deviation 5.2 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter
Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter | -0.13 mm/m^2 | Standard Deviation 1.17 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter | -0.22 mm/m^2 | Standard Deviation 0.98 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine | -0.18 mm/m^2 | Standard Deviation 1.12 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine | -0.07 mm/m^2 | Standard Deviation 1.27 |
| Losartan | Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine | -0.19 mm/m^2 | Standard Deviation 0.96 |
| Losartan + Amlodipine | Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine | -0.24 mm/m^2 | Standard Deviation 1.03 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)
Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) | -0.55 cm3/m^2 | Standard Deviation 17.94 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) | -2.27 cm3/m^2 | Standard Deviation 26.46 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine | -8.88 cm3/m^2 | Standard Deviation 15.74 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine | 7.78 cm3/m^2 | Standard Deviation 17.14 |
| Losartan | Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine | -7.42 cm3/m^2 | Standard Deviation 24.37 |
| Losartan + Amlodipine | Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine | 1.30 cm3/m^2 | Standard Deviation 28.21 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) | LV ejection fraction Teicholz(n=29,36) | 0.00 Percent | Standard Deviation 0.11 |
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) | LV ejection fraction Simpson(n=22,34) | 0.02 Percent | Standard Deviation 0.14 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) | LV ejection fraction Teicholz(n=29,36) | 0.01 Percent | Standard Deviation 0.08 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) | LV ejection fraction Simpson(n=22,34) | 0.00 Percent | Standard Deviation 0.11 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Teicholz (n=14,15,16,20) | 0.00 Percent | Standard Deviation 0.09 |
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Simpson(n=11,11,15,19) | 0.05 Percent | Standard Deviation 0.1 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Simpson(n=11,11,15,19) | -0.01 Percent | Standard Deviation 0.17 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Teicholz (n=14,15,16,20) | -0.00 Percent | Standard Deviation 0.13 |
| Losartan | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Teicholz (n=14,15,16,20) | -0.00 Percent | Standard Deviation 0.07 |
| Losartan | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Simpson(n=11,11,15,19) | -0.02 Percent | Standard Deviation 0.12 |
| Losartan + Amlodipine | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Teicholz (n=14,15,16,20) | 0.01 Percent | Standard Deviation 0.09 |
| Losartan + Amlodipine | Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine | LV ejection fraction Simpson(n=11,11,15,19) | 0.02 Percent | Standard Deviation 0.11 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule | LV end-diastolic volume (n=22,34) | 2.30 ml | Standard Deviation 35.65 |
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule | LV end-systolic volume (n=22,34) | -0.92 ml | Standard Deviation 12.24 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule | LV end-diastolic volume (n=22,34) | 0.54 ml | Standard Deviation 33.19 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule | LV end-systolic volume (n=22,34) | 0.64 ml | Standard Deviation 21.01 |
Secondary
Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-systolic volume (n=11,11, 15,19) | -2.93 ml | Standard Deviation 13.24 |
| Aliskiren | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-diastolic volume (n=11,11,15,19) | 6.60 ml | Standard Deviation 40.43 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-systolic volume (n=11,11, 15,19) | 1.09 ml | Standard Deviation 11.44 |
| Lostaran | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-diastolic volume (n=11,11,15,19) | -2.00 ml | Standard Deviation 31.51 |
| Losartan | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-diastolic volume (n=11,11,15,19) | 5.01 ml | Standard Deviation 38.15 |
| Losartan | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-systolic volume (n=11,11, 15,19) | 6.11 ml | Standard Deviation 23.82 |
| Losartan + Amlodipine | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-diastolic volume (n=11,11,15,19) | -2.98 ml | Standard Deviation 29.3 |
| Losartan + Amlodipine | Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine | LV end-systolic volume (n=11,11, 15,19) | -3.69 ml | Standard Deviation 17.97 |
Secondary
Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)
Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI) | -8.05 g/m^2 | Standard Deviation 18.98 |
| Lostaran | Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI) | -7.96 g/m^2 | Standard Deviation 18.69 |
Secondary
Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine
Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI
Time frame: Baseline, Week 36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine | -5.68 g/m2 | Standard Deviation 18.95 |
| Lostaran | Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine | -10.26 g/m2 | Standard Deviation 19.4 |
| Losartan | Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine | -3.59 g/m2 | Standard Deviation 13.46 |
| Losartan + Amlodipine | Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine | -11.46 g/m2 | Standard Deviation 21.71 |
Secondary
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate
Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP \< 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP \< 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)
Time frame: Baseline, Week10,18,26,36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 10 | 16 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 18 | 24 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 26 | 24 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 36 | 22 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 36 | 25 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 10 | 15 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 26 | 27 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate | Baseline, Week 18 | 21 Patients |
Secondary
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline
The control rate was defined as the proportion of patients with SBP \< 140 mmHg and DBP \< 90 mmHg compared to baseline
Time frame: Week10,18,26,36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 36 | 21 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 10 | 15 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 18 | 20 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 26 | 22 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 26 | 23 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 36 | 20 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 18 | 19 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline | Control rate at Week 10 | 13 Patients |
Secondary
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs
The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide
Time frame: Baseline, Week 10,18,26
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs | Baseline, Week 10 (amlodipine) | 11 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs | Baseline, Week 18 (amlodipine) | 2 Patients |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs | Baseline, Week 26 (hydrochlorothiazide) | 2 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs | Baseline, Week 10 (amlodipine) | 15 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs | Baseline, Week 18 (amlodipine) | 9 Patients |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs | Baseline, Week 26 (hydrochlorothiazide) | 4 Patients |
Secondary
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)
The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values
Time frame: Baseline, Week 10,18,26,36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 10 (n=30,37) | -1.77 mmHg | Standard Deviation 10.22 |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 18 (n=29,36) | -5.34 mmHg | Standard Deviation 10.66 |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 26 (n=29,36) | -5.34 mmHg | Standard Deviation 11.37 |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 36 (n=32,37) | -4.19 mmHg | Standard Deviation 10.32 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 36 (n=32,37) | -6.68 mmHg | Standard Deviation 9.66 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 10 (n=30,37) | -3.15 mmHg | Standard Deviation 10.97 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 26 (n=29,36) | -6.94 mmHg | Standard Deviation 10.1 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP) | Baseline, Week 18 (n=29,36) | -7.07 mmHg | Standard Deviation 9.98 |
Secondary
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)
The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values
Time frame: Baseline, Week 10,18,26,36
Population: Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 10 (n=30,37) | -5.56 mmHg | Standard Deviation 12.89 |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 18 (n=29,36) | -9.77 mmHg | Standard Deviation 12.25 |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 26 (n=29,36) | -12.69 mmHg | Standard Deviation 15.05 |
| Aliskiren | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 36 (n=32,37) | -8.87 mmHg | Standard Deviation 19.26 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 36 (n=32,37) | -8.88 mmHg | Standard Deviation 15.91 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 10 (n=30,37) | -4.03 mmHg | Standard Deviation 16.93 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 26 (n=29,36) | -10.40 mmHg | Standard Deviation 15.74 |
| Lostaran | Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP) | Baseline, Week 18 (n=29,36) | -8.44 mmHg | Standard Deviation 17.3 |