Conditions: Essential Hypertension Type 2 Diabetes Mellitus
Keywords: Drug therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 380
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6.

Interventions: intervention 1: Azilsartan Medoxomil
Intervention descriptions: intervention 1: Azilsartan medoxomil tablets

Protocol document: