Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Left Ventricular Hypertrophy; Overweight
Intervention: Aliskiren 150/300 mg (Drug); Losartan 50/100 mg (Drug); Aliskiren placebo (Drug); Losartan 50/100 mg placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)
Secondary outcome: Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)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) 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) 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) 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) Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) 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) Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36) Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36) Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
sites in Argentina, Argentina, Argentina
sites in Colombia, Colombia, Colombia
sites in Finland, Finland, Finland
sites in Germany, Germany, Germany
sites in Italy, Italy, Italy
sites in Russia, Russia, Russian Federation
sites in Spain, Spain, Spain
sites in Sweden, Sweden, Sweden
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: October 2005
Last updated: May 20, 2011
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