Last updated on September 2017

TAK-491 (Azilsartan Medoxomil) Compared to Valsartan in Chinese Participants With Hypertension

Brief description of study

The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil compared with valsartan in Chinese participants with essential hypertension.

Detailed Study Description

The drug being tested in this study is called TAK-491 (azilsartan medoxomil). Azilsartan medoxomil is being tested to treat Chinese people who have essential hypertension. This study will look at change in blood pressure after 8 weeks of treatment in people who take azilsartan medoxomil compared to people who take valsartan. The study will enroll approximately 600 patients. Prior to the start of study treatment, participants who have not received antihypertensive treatment within 28 days will participate in a 2-week -run in period, and participants taking antihypertensive treatment within 28 days will participate in a 4-week run-in period. Upon completion of the run-in period, participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): - azilsartan medoxomil 40 mg - azilsartan medoxomil 80 mg - Valsartan 160 mg All participants will be asked to take study medication at the same time each day throughout the study. This multi-centre trial will be conducted in China. The overall time to participate in this study is up to 14 weeks. Participants will make 9 visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Clinical Study Identifier: NCT02480764

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