Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is
being tested to treat people who have essential hypertension and type 2 diabetes mellitus
(T2DM). This study will look at the blood pressure of people who take azilsartan medoxomil in
addition to standard care for T2DM.
The study will enroll approximately 380 patients. All participants will receive azilsartan
medoxomil 40 mg tablets to be administered orally, once a day, for 12 weeks. If a
participant's blood pressure (BP) has not reached BP goal of <140/85 mmHg at week 6,
azilsartan medoxomil dose will be up-titrated to 80 mg daily.
All participants will be asked to take one tablet at the same time each day throughout the
study.
This multi-center trial will be conducted in Asia. The overall time to participate in this
study is 14 weeks. Participants will make multiple visits to the clinic, and will be
contacted by 14 days after last dose of study drug for a follow-up assessment.
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