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

This study has been completed.

First Received: August 29, 2005 Last Updated: March 20, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00139555

Purpose

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.

Condition	Intervention	Phase
Hypertension Left Ventricular Hypertrophy	Drug: amlodipine/benazepril	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Benazepril hydrochloride Benazepril Amlodipine Amlodipine besylate Lotrel

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	168
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139555

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CCIB002FUS16
Study First Received:	August 29, 2005
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00139555 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension
Left ventricular hypertrophy

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Amlodipine
Membrane Transport Modulators
Hypertrophy
Therapeutic Uses
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Cardiomegaly
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010