Phase 3 N=460 Randomized Double-blind Treatment

Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension

Hypertension · Left Ventricular Hypertrophy · Overweight

Bottom Line

View on ClinicalTrials.gov: NCT00219141 ↗

Enrolled (actual)

460

Serious AEs

7.2%

Results posted

May 2011

Primary outcome: Primary: Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) — -5.51; -4.81; -5.61 g/m^2

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Aliskiren 150/300 mg (Drug); Losartan 50/100 mg (Drug); Aliskiren placebo (Drug); Losartan 50/100 mg placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)	-5.51; -4.81; -5.61	—
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)	-4.87; -4.79; -5.81	—
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)	-7.05; -4.52; -7.03	—
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)	-3.20; -4.73; -5.14	—
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)	-0.95; -1.20; -1.17	—
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)	-0.88; -0.89; -0.90	—
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)	-0.71; -0.64; -0.86	—
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)	-9.81; -9.92; -12.29	—
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)	0.62; 2.02; 1.92	—
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)	-3.89; 0.24; -2.24	—
SECONDARY 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; -0.97; -1.43	—
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)	-104.97; -150.31; -130.65	—
SECONDARY Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)	-2.67; -3.81; -6.97; -1.31; -1.92; -4.11	—

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.

Eligibility Criteria

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/exclusion criteria applied to the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00219141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.