Phase 3 Completed N=1,071 Randomized Quadruple-blind Treatment

Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.

Hypertension

Source: ClinicalTrials.gov NCT01033071 ↗

Enrolled (actual)

1,071

Serious AEs

1.8%

Results posted

Feb 2012

Primary outcomePrimary: Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. — -42.5; -44.0; -37.1 mmHg — p=<0.001

Summary

The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in participants with moderate to severe hypertension.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.	-34.7; -36.7; -29.7; -39.1; -39.4; -33.5	—
SECONDARY Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.	-34.7; -36.7; -29.7; -39.1; -39.4; -33.5	—
SECONDARY Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.	-14.9; -15.8; -11.7; -17.0; -17.7; -13.9	—
SECONDARY Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-32.9; -34.9; -25.9	<0.001 sig
SECONDARY Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-19.8; -20.2; -16.0	—
SECONDARY Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-33.9; -36.3; -27.5	<0.001 sig
SECONDARY Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-19.4; -20.7; -16.2	—
SECONDARY Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-35.3; -37.9; -28.8	—
SECONDARY Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-20.1; -21.8; -17.0	—
SECONDARY Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-29.6; -31.8; -23.9	—
SECONDARY Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.	-17.5; -18.0; -14.0	—
SECONDARY Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.	-36.2; -38.8; -29.7	—
SECONDARY Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.	-20.4; -22.2; -17.5	—
SECONDARY Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.	-33.6; -36.2; -26.8; -33.4; -36.4; -27.5	—
SECONDARY Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.	-18.2; -20.4; -15.2; -18.8; -20.9; -15.9	—
SECONDARY Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.	87.8; 90.0; 79.8; 93.3; 92.4; 85.6	—
SECONDARY Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.	89.2; 89.7; 85.2; 90.7; 90.9; 87.8	—
SECONDARY Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.	81.3; 84.8; 74.4; 88.1; 87.3; 81.0	—

Eligibility Criteria

Inclusion Criteria

Has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg.
Females of childbearing potential who are sexually active agree to routinely use adequate contraception from Screening through 30 days after the last administered study drug dose.
Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant.
Is willing to discontinue current antihypertensive medications on Day -21 or Day -28 if the participant is on amlodipine or chlorthalidone.

Exclusion Criteria

Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on Day -1.
Has a baseline 24-hour ambulatory blood pressure monitoring reading of insufficient quality.
Works a night (third) shift.
Has an upper arm circumference less than 24 cm or greater than 42 cm.
Has secondary hypertension of any etiology.
Has a recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Has clinically significant cardiac conduction defects.
Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Has severe renal dysfunction or disease.
Has known or suspected unilateral or bilateral renal artery stenosis.
Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
Has poorly-controlled diabetes mellitus at Screening.
Has hypokalemia or hyperkalemia.
Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.
Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds.
Has a history of drug abuse or a history of alcohol abuse within the past 2 years.

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Data sourced from ClinicalTrials.gov (NCT01033071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.