NCT02480764

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

A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Chinese Subjects With Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 612 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 enrolled 612 patients. Prior to the start of study treatment, participants who have not received antihypertensive treatment within 28 days participated in a 2-week -run in period. Upon completion of the run-in period, participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which 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 were asked to take study medication at the same time each day throughout the study. This multi-centre trial was conducted in China. The overall time to participate in this study is up to 14 weeks. Participants made 9 visits to the clinic and contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Azilsartan medoxomil	Azilsartan medoxomil tablets
DRUG	Valsartan	Valsartan 80 mg capsules
DRUG	Azilsartan medoxomil Placebo	Azilsartan medoxomil placebo-matching tablets
DRUG	Valsartan Placebo	Valsartan placebo-matching capsules

Timeline

• Start date: 2015-08-27
• Primary completion: 2017-09-22
• Completion: 2017-10-13
• First posted: 2015-06-24
• Last updated: 2019-03-05
• Results posted: 2019-02-11

Locations

30 sites across 1 country: China