Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

Phase 3 Completed 571 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of Black stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Timeline

Start: 2006-06
Primary completion: 2007-04
Completion: 2007-04

Publications

Results Flack JM, Calhoun DA, Satlin L, Barbier M, Hilkert R, Brunel P. Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study. J Hum Hypertens. 2009 Jul;23(7):479-89. doi: 10.1038/jhh.2008.153. Epub 2009 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	5 mg	Oral
Subject	Amlodipine	Other / unclassified	10 mg	Oral
Subject	Valsartan	Small molecule	160 mg	Oral
Subject	Valsartan	Small molecule	320 mg	Oral

Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

Summary

Timeline

Publications

Drugs

Indications