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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00219141
Other study ID # CSPP100A2316
Secondary ID
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


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
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