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NCT00139555 Clinical Trial

Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Hypertension Clinical Trial

Official title:
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139555
Other study ID # CCIB002FUS16
Secondary ID
Status Completed
Phase Phase 4
First received August 29, 2005
Last updated February 21, 2017
Start date July 2004
Est. completion date November 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• amlodipine/benazepril

Locations
Country Name City State
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Hyperten — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in left ventricular mass index after 52 weeks
Secondary Change from baseline in left ventricular mass after 52 weeks
Secondary Change from baseline in diastolic function after 52 weeks
Secondary Change from baseline in aorta function assessed blood pressure measurements after 52 weeks
Secondary Change from baseline in markers of fibrosis and increased heart size after 52 weeks
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