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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Azilsartan medoxomil tablets
Unnamed facility
Hong Kong, Hong Kong, China
Unnamed facility
Changhua County, Taiwan
Unnamed facility
Kaohsiung City, Taiwan
Unnamed facility
Taichung, Taiwan
Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg
Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Up to Week 12
Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg
At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Weeks 6 and 12
Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Weeks 6 and 12
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg
At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Weeks 6 and 12
Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg
Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
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Unnamed facility
Tainan, Taiwan
Unnamed facility
Taipei, Taiwan
Unnamed facility
Taoyuan County, Taiwan
Unnamed facility
Bangkok, Thailand
Unnamed facility
Chiang Mai, Thailand
Unnamed facility
Khon Kaen, Thailand
...and 1 more locations
Time frame: Up to Week 12
Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Weeks 6 and 12
Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Weeks 6 and 12
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Weeks 6 and 12
Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Percentage of Participants With DBP <90 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Percentage of Participants With BP <130/80 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Percentage of Participants With SBP <130 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Percentage of Participants With DBP <80 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Percentage of Participants With BP <140/90 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Change From Baseline in Trough Sitting SBP at Week 12
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline in DBP at Week 12
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12