Back to resultsEffects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
Primary Purpose
Hypertension, Left Ventricular Hypertrophy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
amlodipine/benazepril
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Left ventricular hypertrophy
Eligibility 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
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Change from baseline in left ventricular mass index after 52 weeks
Secondary Outcome 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00139555
Brief Title
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
Official Title
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Left Ventricular Hypertrophy
Keywords
Hypertension, Left ventricular hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amlodipine/benazepril
Primary Outcome Measure Information:
Title
Change from baseline in left ventricular mass index after 52 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in left ventricular mass after 52 weeks
Title
Change from baseline in diastolic function after 52 weeks
Title
Change from baseline in aorta function assessed blood pressure measurements after 52 weeks
Title
Change from baseline in markers of fibrosis and increased heart size after 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19687350
Citation
Reichek N, Devereux RB, Rocha RA, Hilkert R, Hall D, Purkayastha D, Pitt B. Magnetic resonance imaging left ventricular mass reduction with fixed-dose angiotensin-converting enzyme inhibitor-based regimens in patients with high-risk hypertension. Hypertension. 2009 Oct;54(4):731-7. doi: 10.1161/HYPERTENSIONAHA.109.130641. Epub 2009 Aug 17.
Results Reference
result
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Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
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