Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk 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
Intervention: amlodipine/benazepril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and
mortality in patients with high blood pressure, compared to those without LVH. Reduction of
left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical
outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in
patients with high risk hypertension.
Clinical Details
Official title: Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in left ventricular mass index after 52 weeks
Secondary outcome: Change from baseline in left ventricular mass after 52 weeksChange from baseline in diastolic function after 52 weeks Change from baseline in aorta function assessed blood pressure measurements after 52 weeks Change from baseline in markers of fibrosis and increased heart size after 52 weeks
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or female patients ≥ 55 years of age
- LVH as confirmed by echocardiogram
- Patients with high risk hypertension, currently treated or already taking
antihypertensive medication
Exclusion Criteria:
- Renal artery stenosis
- Symptomatic heart failure or known ejection fraction < 40%
- Myocardial infarction or stroke within 6 months
- Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers
- Pregnant or lactating females
- Cancer within the last 5 years
Locations and Contacts
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: July 2004
Last updated: March 20, 2008
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