Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Left Ventricular Hypertrophy; Overweight
Intervention: aliskiren (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: Change from baseline in left heart ventricle mass using magnetic resonance imaging from baseline to after week 36
Secondary outcome: Change from baseline in size of left heart ventricle measured by magnetic resonance and electrocardiogram from baseline to after week 36
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
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).
Locations and Contacts
Investigative Centers, Germany
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: August 2005
Last updated: December 6, 2007
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