The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil versus placebo in Korean adults with essential hypertension.
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat Korean adults with hypertension. This study will look at changes in blood pressure in people who take azilsartan medoxomil. The study will enroll approximately 325 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will 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 * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient. All participants will be asked to take two tablets at the same time each day throughout the study. This multi-centre trial will be conducted in Korea. The overall time to participate in this study is 12 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
328
Azilsartan medoxomil tablets
Azilsartan medoxomil placebo-matching tablets
Unnamed facility
Chuncheon, Gangwon-do, South Korea
Unnamed facility
Wŏnju, Gangwon-do, South Korea
Unnamed facility
Anyang-si, Gyeonggi-do, South Korea
Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)
The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)
The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.
Time frame: Baseline and Week 6
Percentage of Participants Who Achieved a Clinic DBP Response at Week 6
Clinic DBP response is defined as clinic DBP \<90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.
Time frame: Baseline and Week 6
Percentage of Participants Who Achieved a Clinic SBP Response at Week 6
SBP response is defined as clinic SBP \<140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.
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Unnamed facility
Goyang-si, Gyeonggi-do, South Korea
Unnamed facility
Seongnam-si, Gyeonggi-do, South Korea
Unnamed facility
Suwon, Gyeonggi-do, South Korea
Unnamed facility
Daegu, Gyeongsangbuk-do, South Korea
Unnamed facility
Yangsan, Gyeongsangnam-do, South Korea
Unnamed facility
Jeonju, Jeollabuk-do, South Korea
Unnamed facility
Gwangju, Jeollanam-do, South Korea
...and 5 more locations
Time frame: Baseline and Week 6
Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6
Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP \<90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP \<140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.
Time frame: Baseline and Week 6