NCT02517866

Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia

A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Hypertension
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Azilsartan Medoxomil	Azilsartan medoxomil tablets

Timeline

• Start date: 2015-07-13
• Primary completion: 2016-11-15
• Completion: 2016-11-25
• First posted: 2015-08-07
• Last updated: 2019-03-01
• Results posted: 2019-03-01

Locations

11 sites across 3 countries: China, Taiwan, Thailand