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

Hypertension Clinical Trial

— ALLAY  

Official title:

A 36-week, Randomized, Double-blind, Multi-center, Parallel Group Study Comparing the Efficacy and Safety of Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219141
• Other study ID #: CSPP100A2316
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 20, 2011
• Start date: October 2005
• Est. completion date: November 2007

Study information

• Verified date: May 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy
• Overweight

Intervention

Drug:
• Aliskiren 150/300 mg
Aliskiren 150 mg tablets
• Losartan 50/100 mg
Losartan 50 or 100 mg capsules
• Aliskiren placebo
Aliskiren 150 mg placebo tablet
• Losartan 50/100 mg placebo
Losartan 50/100 mg placebo capsules

Locations

Country	Name	City	State
Argentina	sites in Argentina	Argentina
Colombia	sites in Colombia	Colombia
Finland	sites in Finland	Finland
Germany	sites in Germany	Germany
Italy	sites in Italy	Italy
Russian Federation	sites in Russia	Russia
Spain	sites in Spain	Spain
Sweden	sites in Sweden	Sweden
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  Finland,  Germany,  Italy,  Russian Federation,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
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)		Baseline to end of study (Week 36)	No
Secondary	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)	No
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)		Baseline to end of study (Week 36)	No
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.	Baseline the end of study (Week 36)	No