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

Phase 4 Completed 125 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-07
Primary completion: 2006-11
Completion: 2006-11

Outcome

Missed primary endpoint

paper with a mean difference between treatment groups of 3.36 g/m(2) (P=0.16). PMID 19687350 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	5 mg	—
Subject	Amlodipine	Other / unclassified	10 mg	—
Subject	Benazepril	Unknown	20 mg	—
Subject	Benazepril	Unknown	40 mg	—