Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension

Summary

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.

Timeline

Start

2007-10

Primary completion

2009-03

Completion

2009-04

Outcome

Met primary endpoint

registry Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD vs Amlodipine 5 mg QD; p <0.001; Mean Difference (Final Values) -11.19 (95% CI -13.29 to -9.09) NCT00591266 ↗

registry Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD vs Amlodipine 5 mg QD; p <0.001; Mean Difference (Final Values) -10.91 (95% CI -13.00 to -8.81) NCT00591266 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azilsartan medoxomil	Other / unclassified	40 mg	Oral
Subject	Azilsartan medoxomil	Other / unclassified	80 mg	Oral
Background	Amlodipine	Other / unclassified	5 mg	Oral

Indications