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Trial record 56 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)

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ClinicalTrials.gov Identifier: NCT01176032
Recruitment Status : Completed
First Posted : August 5, 2010
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypertension
Left Ventricle Hypertrophy
Interventions Drug: Aliskiren
Drug: Losartan
Drug: Amlodipine
Drug: Hydrochlorothiazide (HCTZ)
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aliskiren Lostaran
Hide Arm/Group Description Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Period Title: Overall Study
Started 37 [1] 37
Intention-to-treat (ITT) Population 32 37
Completed 31 36
Not Completed 6 1
Reason Not Completed
Adverse Event             1             0
Unsatisfactory therapeutic effect             0             1
Protocol Violation             1             0
Informed consent withdrawn             3             0
Not available             1             0
[1]
"Started" indicates randomized and safety population
Arm/Group Title Aliskiren Lostaran Total
Hide Arm/Group Description Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks Total of all reporting groups
Overall Number of Baseline Participants 32 37 69
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 37 participants 69 participants
60.34  (9.34) 58.05  (10.34) 59.12  (9.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 37 participants 69 participants
Female
9
  28.1%
11
  29.7%
20
  29.0%
Male
23
  71.9%
26
  70.3%
49
  71.0%
1.Primary Outcome
Title Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: ug/l
-5.22  (20.37) -4.25  (24.80)
2.Secondary Outcome
Title Change From Baseline in Biomarkers in Heart Disease
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: ng/ml
cardiotrophin-1 (CT-1) (n=32,37) -169.15  (561.51) -128.23  (568.02)
matrix metalloproteinase-1 (MMP-1) (n=32,37) 5.93  (13.33) 5.51  (9.58)
tissue inhibitor of MMPs (TIMP-1) (n=32,37) -0.70  (59.18) 9.15  (42.58)
annexin A5 (AnxA5) (n=31,37) -0.98  (7.33) -1.21  (4.75)
NT-proBNP (n=31,34) 18.66  (165.21) -7.55  (38.11)
3.Secondary Outcome
Title Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: ng/dl
-1.81  (27.78) -7.90  (76.35)
4.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: ml
LV end-diastolic volume (n=22,34) 2.30  (35.65) 0.54  (33.19)
LV end-systolic volume (n=22,34) -0.92  (12.24) 0.64  (21.01)
5.Secondary Outcome
Title Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: Percent
LV ejection fraction Teicholz(n=29,36) 0.00  (0.11) 0.01  (0.08)
LV ejection fraction Simpson(n=22,34) 0.02  (0.14) 0.00  (0.11)
6.Secondary Outcome
Title Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter
Hide Description Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter
Time Frame Baseline, Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 24 30
Mean (Standard Deviation)
Unit of Measure: mm/m^2
-0.13  (1.17) -0.22  (0.98)
7.Secondary Outcome
Title Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 12 22
Mean (Standard Deviation)
Unit of Measure: cm3/m^2
-0.55  (17.94) -2.27  (26.46)
8.Secondary Outcome
Title Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: g/m^2
-8.05  (18.98) -7.96  (18.69)
9.Secondary Outcome
Title Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Aliskiren + Amlodipine Losartan Losartan + Amlodipine
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Overall Number of Participants Analyzed 15 17 16 21
Mean (Standard Deviation)
Unit of Measure: ng/ml
CT-1(n=15,17,16,21) -289.18  (608.91) -63.23  (510.91) 156.89  (599.29) -345.47  (443.63)
ANXA5 (n=15,16,16,21) -1.24  (3.70) -0.74  (9.73) -1.73  (4.21) -0.81  (5.20)
MMP-1(n=15,17,16,21) 7.00  (10.28) 4.99  (15.80) 5.47  (7.88) 5.54  (10.89)
TIMP-1 (n=15,17,16,21) -10.01  (73.00) 7.51  (44.38) 21.38  (38.40) -0.16  (44.13)
NT-proBNP (n=15,16,15,19) 21.00  (214.06) 16.46  (108.69) -3.68  (23.78) -10.60  (46.91)
10.Secondary Outcome
Title Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Aliskiren + Amlodipine Losartan Losartan + Amlodipine
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Overall Number of Participants Analyzed 15 17 16 21
Mean (Standard Deviation)
Unit of Measure: ng/dl
2.81  (21.36) -5.89  (32.54) -3.12  (32.45) -11.55  (98.35)
11.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Aliskiren + Amlodipinet Losartan Losartan + Amlodipine
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Overall Number of Participants Analyzed 15 17 16 21
Mean (Standard Deviation)
Unit of Measure: ml
LV end-diastolic volume (n=11,11,15,19) 6.60  (40.43) -2.00  (31.51) 5.01  (38.15) -2.98  (29.30)
LV end-systolic volume (n=11,11, 15,19) -2.93  (13.24) 1.09  (11.44) 6.11  (23.82) -3.69  (17.97)
12.Secondary Outcome
Title Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Aliskiren + Amlodipinet Losartan Losartan + Amlodipine
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Overall Number of Participants Analyzed 15 17 16 21
Mean (Standard Deviation)
Unit of Measure: Percent
LV ejection fraction Teicholz (n=14,15,16,20) 0.00  (0.09) -0.00  (0.13) -0.00  (0.07) 0.01  (0.09)
LV ejection fraction Simpson(n=11,11,15,19) 0.05  (0.10) -0.01  (0.17) -0.02  (0.12) 0.02  (0.11)
13.Secondary Outcome
Title Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine
Hide Description Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter
Time Frame Baseline, Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Aliskiren + Amlodipinet Losartan Losartan + Amlodipine
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Overall Number of Participants Analyzed 12 12 13 17
Mean (Standard Deviation)
Unit of Measure: mm/m^2
-0.18  (1.12) -0.07  (1.27) -0.19  (0.96) -0.24  (1.03)
14.Secondary Outcome
Title Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Aliskiren + Amlodipinet Losartan Losartan + Amlodipine
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Overall Number of Participants Analyzed 6 6 9 13
Mean (Standard Deviation)
Unit of Measure: cm3/m^2
-8.88  (15.74) 7.78  (17.14) -7.42  (24.37) 1.30  (28.21)
15.Secondary Outcome
Title Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Aliskiren + Amlodipinet Losartan Losartan + Amlodipine
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Overall Number of Participants Analyzed 14 15 16 20
Mean (Standard Deviation)
Unit of Measure: g/m2
-5.68  (18.95) -10.26  (19.40) -3.59  (13.46) -11.46  (21.71)
16.Secondary Outcome
Title Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline, Week 10 (n=30,37) -5.56  (12.89) -4.03  (16.93)
Baseline, Week 18 (n=29,36) -9.77  (12.25) -8.44  (17.30)
Baseline, Week 26 (n=29,36) -12.69  (15.05) -10.40  (15.74)
Baseline, Week 36 (n=32,37) -8.87  (19.26) -8.88  (15.91)
17.Secondary Outcome
Title Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline, Week 10 (n=30,37) -1.77  (10.22) -3.15  (10.97)
Baseline, Week 18 (n=29,36) -5.34  (10.66) -7.07  (9.98)
Baseline, Week 26 (n=29,36) -5.34  (11.37) -6.94  (10.10)
Baseline, Week 36 (n=32,37) -4.19  (10.32) -6.68  (9.66)
18.Secondary Outcome
Title Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Measure Type: Number
Unit of Measure: Patients
Baseline, Week 10 16 15
Baseline, Week 18 24 21
Baseline, Week 26 24 27
Baseline, Week 36 22 25
19.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Measure Type: Number
Unit of Measure: Patients
Control rate at Week 10 15 13
Control rate at Week 18 20 19
Control rate at Week 26 22 23
Control rate at Week 36 21 20
20.Secondary Outcome
Title Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs
Hide Description 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
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Hide Analysis Population Description
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/Group Title Aliskiren Lostaran
Hide Arm/Group Description:
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
Overall Number of Participants Analyzed 32 37
Measure Type: Number
Unit of Measure: Patients
Baseline, Week 10 (amlodipine) 11 15
Baseline, Week 18 (amlodipine) 2 9
Baseline, Week 26 (hydrochlorothiazide) 2 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren Losartan
Hide Arm/Group Description Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
All-Cause Mortality
Aliskiren Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   2/37 (5.41%)   0/37 (0.00%) 
Infections and infestations     
Bronchopneumonia  1  1/37 (2.70%)  0/37 (0.00%) 
Surgical and medical procedures     
Coronary artery bypass  1  1/37 (2.70%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aliskiren Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   12/37 (32.43%)   16/37 (43.24%) 
Cardiac disorders     
Palpitations  1  2/37 (5.41%)  5/37 (13.51%) 
Gastrointestinal disorders     
Abdominal pain  1  2/37 (5.41%)  0/37 (0.00%) 
Diarrhoea  1  1/37 (2.70%)  2/37 (5.41%) 
Vomiting  1  0/37 (0.00%)  2/37 (5.41%) 
General disorders     
Oedema peripheral  1  3/37 (8.11%)  0/37 (0.00%) 
Infections and infestations     
Bronchitis  1  0/37 (0.00%)  2/37 (5.41%) 
Gastroenteritis  1  1/37 (2.70%)  3/37 (8.11%) 
Influenza  1  1/37 (2.70%)  4/37 (10.81%) 
Nasopharyngitis  1  1/37 (2.70%)  3/37 (8.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/37 (2.70%)  2/37 (5.41%) 
Back pain  1  2/37 (5.41%)  2/37 (5.41%) 
Nervous system disorders     
Dizziness  1  4/37 (10.81%)  3/37 (8.11%) 
Headache  1  4/37 (10.81%)  6/37 (16.22%) 
Renal and urinary disorders     
Renal colic  1  2/37 (5.41%)  1/37 (2.70%) 
Vascular disorders     
Hypertension  1  2/37 (5.41%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 or disclosure of trial results in their entirety
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01176032     History of Changes
Other Study ID Numbers: CSPP100AES02
2009-016735-36 ( EudraCT Number )
First Submitted: August 2, 2010
First Posted: August 5, 2010
Results First Submitted: April 22, 2014
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014