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

NCT ID: NCT00139555

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Left Ventricular Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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amlodipine/benazepril

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19687350 (View on PubMed)

Other Identifiers

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CCIB002FUS16

Identifier Type: -

Identifier Source: org_study_id

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