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...
Date First Received: August 29, 2005
Last Updated: March 20, 2008
Verified by: Novartis, March 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2004
Overall Status: Completed
Estimated Enrollment: 168
Brief Summary
Official Title: “Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: amlodipine/benazepril
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in left ventricular mass index after 52 weeks
Secondary Measures
- Change from baseline in left ventricular mass after 52 weeks
- Change 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 55 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139555
Study ID Number: CCIB002FUS16
ClinicalTrials.gov Identifier: NCT00139555
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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