CompletedNCT00696436Updated Apr 19, 2011Results posted

An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.

A Phase 3 interventional study of Azilsartan medoxomil and Azilsartan medoxomil in Hypertension, sponsored by Takeda. Completed at 131 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-19.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,291
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential hypertension.

Read the detailed description

Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled: only about one-third of patients successfully maintain control.

A major component of blood pressure regulation is the renin-angiotensin-aldosterone system. This is a system of hormone-mediated feedback interactions that result in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal pressor agent of the renin-angiotensin-aldosterone system and has multiple effects on the cardiovascular system and on electrolyte homeostasis.

TAK-491 (azilsartan medoxomil) is an angiotensin II type 1 receptor antagonist currently being tested as a treatment for essential hypertension.

Study participation is anticipated to be about 10 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations, electrocardiograms and ambulatory blood pressure monitoring. Outside of the study center, participants will be required wear an ambulatory blood pressure monitoring device at 24 hour intervals.

Conditions studied

Hypertension

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Keywords

Essential Hypertension
Cardiovascular Disease
High Blood Pressure
Drug Therapy

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 1,291 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Essential hypertension (sitting systolic blood pressure between 150 and 180 mm Hg, inclusive, at Day -1 and 24-hour mean systolic blood pressure between 130 and 170 mm Hg, inclusive, at Day 1).
Capable of understanding and complying with protocol requirements.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
Clinical laboratory evaluations within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Willing to discontinue current antihypertensive medications at Screening Day 21 visit. If the participant is on amlodipine prior to Screening, the participant is willing to discontinue this medication at Screening Day -28.

Exclusion criteria

Exclusion Criteria:

Sitting diastolic blood pressure greater than 114 mm Hg at Day -1 (day prior to Randomization).
Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
Taking or expected to take an excluded medication as described in the Excluded Medications.
Hypersensitive to angiotensin II receptor blockers.
History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Clinically significant cardiac conduction defects.
Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Secondary hypertension of any etiology.
Noncompliant (less than 70% or greater than 130%) with study medication during run-in period.
Moderate to severe renal dysfunction or disease.
Known or suspected unilateral or bilateral renal artery stenosis.
History of drug or alcohol abuse within the past 2 years.
Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those participants with basal cell or stage I squamous cell carcinoma of the skin).
Type 1 or poorly-controlled type 2 diabetes mellitus (glycosylate hemoglobin greater than 8.0%) at Screening.
Hyperkalemia as defined by the central laboratory normal reference range at Screening.
Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
Upper arm circumference less than 24 cm or greater than 42 cm.
Works night (3rd) shift (defined as 11 PM [2300] to 7 AM [0700]).
Unwilling or unable to comply with the protocol or scheduled appointments.
Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to Randomization.
Any other serious disease or condition at Screening or Randomization that would compromise participant's safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.
Has been randomized in a previous azilsartan medoxomil study.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,291 participants (actual)

Study arms

Experimental
Azilsartan Medoxomil 40 mg QD
Drug: Azilsartan medoxomil
Experimental
Azilsartan Medoxomil 80 mg QD
Drug: Azilsartan medoxomil
Active comparator
Valsartan 320 mg QD
Drug: Valsartan
Active comparator
Olmesartan 40 mg QD
Drug: Olmesartan
Placebo comparator
Placebo QD
Drug: Placebo

Interventions

DrugAzilsartan medoxomil
Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks. Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.
Also known as: TAK-491, Edarbi
DrugAzilsartan medoxomil
Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks. Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.
Also known as: TAK-491, Edarbi
DrugValsartan
Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks. Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.
Also known as: Diovan®
DrugOlmesartan
Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks. Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.
Also known as: Benicar®
DrugPlacebo
Matching placebo, orally, once daily for up to six weeks.

What researchers measure

Primary outcomes

Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time frame: Baseline and Week 6.

Secondary outcomes

Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.
Time frame: Baseline and Week 6.
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time frame: Baseline and Week 6.
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.
Time frame: Baseline and Week 6.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time frame: Baseline and Week 6.
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time frame: Baseline and Week 6.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time frame: Baseline and Week 6.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time frame: Baseline and Week 6.
Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time frame: Baseline and Week 6.
Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time frame: Baseline and Week 6.
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 6.
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 6.
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Time frame: Baseline and Week 6.
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Time frame: Baseline and Week 6.
Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.
Time frame: Baseline and Week 6.

Results

Posted Apr 19, 2011

Participant flow

Participants enrolled at 141 investigative sites in Guatemala, Mexico, Peru, Puerto Rico and the United States from 02 April 2008 to 19 August 2009.

Participant flow — Overall Study
Milestone	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Started	280	285	282	290	154
Completed	257	255	254	268	141
Not completed	23	30	28	22	13
Withdrew: Adverse event	7	9	8	6	4
Withdrew: Protocol violation	3	2	2	0	1
Withdrew: Lost to follow-up	1	6	2	4	3
Withdrew: Withdrawal by subject	4	11	5	7	1
Withdrew: Lack of efficacy	3	1	5	2	4
Withdrew: Participant unavailability	2	0	2	1	0
Withdrew: Administrative error	2	0	2	0	0
Withdrew: Participant non-compliance	0	0	1	2	0
Withdrew: Administrative decision	1	0	0	0	0
Withdrew: Missing	0	1	1	0	0

Outcome measures

PrimaryChange From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-13.42 ± 0.690	-14.53 ± 0.702	-10.22 ± 0.696	-11.99 ± 0.666	-0.25 ± 0.917

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -14.27 · 95% CI -16.54 to -12.01
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -13.16 · 95% CI -15.41 to -10.91
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.009 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -2.54 · 95% CI -4.44 to -0.64
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -4.31 · 95% CI -6.25 to -2.37
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.136 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -1.43 · 95% CI -3.31 to 0.45
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -3.20 · 95% CI -5.12 to -1.27

SecondaryChange From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.

The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.	-16.38 ± 0.959	-16.74 ± 0.957	-11.31 ± 0.955	-13.20 ± 0.935	-1.83 ± 1.293

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -14.92 · 95% CI -18.07 to -11.76
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -14.55 · 95% CI -17.71 to -11.40
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.008 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -3.54 · 95% CI -6.17 to -0.92
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -5.43 · 95% CI -8.09 to -2.78
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.018 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -3.18 · 95% CI -5.81 to -0.55
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.) · Mean difference (final values): -5.07 · 95% CI -7.73 to -2.42

SecondaryChange From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-8.65 ± 0.472	-9.43 ± 0.480	-7.09 ± 0.476	-7.74 ± 0.456	-0.07 ± 0.627

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -9.36 · 95% CI -10.91 to -7.81
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -8.58 · 95% CI -10.12 to -7.04
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.011 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.70 · 95% CI -2.99 to -0.40
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.35 · 95% CI -3.67 to -1.02
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.166 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -0.91 · 95% CI -2.19 to 0.38
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.020 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.56 · 95% CI -2.88 to -0.24

SecondaryChange From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure

The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure	-6.97 ± 0.552	-8.27 ± 0.551	-5.11 ± 0.550	-6.10 ± 0.538	-0.76 ± 0.744

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -7.51 · 95% CI -9.33 to -5.69
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -6.21 · 95% CI -8.03 to -4.39
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.005 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.18 · 95% CI -3.69 to -0.67
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -3.17 · 95% CI -4.69 to -1.64
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.257 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -0.87 · 95% CI -2.39 to 0.64
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.017 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.86 · 95% CI -3.39 to -0.33

SecondaryChange From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-13.73 ± 0.724	-15.02 ± 0.736	-10.26 ± 0.730	-12.16 ± 0.699	-0.11 ± 0.963

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -14.92 · 95% CI -17.30 to -12.54
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -13.63 · 95% CI -15.99 to -11.27
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.005 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.86 · 95% CI -4.85 to -0.87
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -4.76 · 95% CI -6.80 to -2.73
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.119 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.57 · 95% CI -3.55 to 0.40
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -3.47 · 95% CI -5.49 to -1.45

SecondaryChange From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-8.96 ± 0.510	-9.80 ± 0.518	-7.23 ± 0.514	-7.82 ± 0.492	0.01 ± 0.677

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -9.81 · 95% CI -11.48 to -8.13
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -8.96 · 95% CI -10.63 to -7.30
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.006 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.99 · 95% CI -3.39 to -0.58
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.57 · 95% CI -4.00 to -1.14
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.107 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.14 · 95% CI -2.53 to 0.25
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.017 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.73 · 95% CI -3.15 to -0.30

SecondaryChange From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-12.28 ± 0.778	-13.32 ± 0.792	-9.66 ± 0.784	-11.90 ± 0.752	-0.31 ± 1.035

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -13.00 · 95% CI -15.56 to -10.45
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -11.97 · 95% CI -14.51 to -9.43
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.194 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.42 · 95% CI -3.56 to 0.72
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -3.65 · 95% CI -5.84 to -1.46
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.720 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -0.39 · 95% CI -2.51 to 1.73
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.018 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.62 · 95% CI -4.79 to -0.45

SecondaryChange From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-7.65 ± 0.540	-8.54 ± 0.550	-6.26 ± 0.544	-7.82 ± 0.522	0.10 ± 0.718

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -8.64 · 95% CI -10.42 to -6.87
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -7.75 · 95% CI -9.52 to -5.99
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.341 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -0.72 · 95% CI -2.21 to 0.77
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.003 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.28 · 95% CI -3.80 to -0.76
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.821 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): 0.17 · 95% CI -1.30 to 1.64
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.071 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.39 · 95% CI -2.89 to 0.12

SecondaryChange From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-14.03 ± 0.764	-15.55 ± 0.777	-10.44 ± 0.770	-12.23 ± 0.738	-0.10 ± 1.016

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -15.45 · 95% CI -17.96 to -12.94
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -13.93 · 95% CI -16.42 to -11.43
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.002 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -3.32 · 95% CI -5.42 to -1.22
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -5.11 · 95% CI -7.26 to -2.97
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.091 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.80 · 95% CI -3.88 to 0.29
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -3.59 · 95% CI -5.72 to -1.46

SecondaryChange From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-9.16 ± 0.542	-10.13 ± 0.551	-7.42 ± 0.547	-7.82 ± 0.524	0.01 ± 0.721

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -10.14 · 95% CI -11.92 to -8.36
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -9.17 · 95% CI -10.94 to -7.40
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.002 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.31 · 95% CI -3.81 to -0.82
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.71 · 95% CI -4.24 to -1.19
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.076 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.34 · 95% CI -2.82 to 0.14
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.024 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.74 · 95% CI -3.25 to -0.22

SecondaryChange From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-12.46 ± 0.860	-13.38 ± 0.873	-9.14 ± 0.865	-11.65 ± 0.829	-0.55 ± 1.142

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -12.84 · 95% CI -15.66 to -10.02
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -11.91 · 95% CI -14.72 to -9.11
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.149 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -1.74 · 95% CI -4.10 to 0.62
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -4.24 · 95% CI -6.65 to -1.83
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.494 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -0.82 · 95% CI -3.16 to 1.53
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.007 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -3.32 · 95% CI -5.72 to -0.93

SecondaryChange From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.

Time frame:: Baseline and Week 6.
Reported as:: Least squares mean · mmHg

Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-8.69 ± 0.648	-8.61 ± 0.657	-6.22 ± 0.651	-8.25 ± 0.624	-0.69 ± 0.859

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -7.91 · 95% CI -10.03 to -5.79
Azilsartan Medoxomil 40 mg QD vs Placebo QD · ANCOVA · p = <0.001 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -7.99 · 95% CI -10.10 to -5.88
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.691 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -0.36 · 95% CI -2.14 to 1.42
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.010 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.39 · 95% CI -4.20 to -0.57
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · ANCOVA · p = 0.625 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -0.44 · 95% CI -2.20 to 1.32
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · ANCOVA · p = 0.008 (Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.) · Mean difference (final values): -2.46 · 95% CI -4.27 to -0.66

SecondaryPercentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg

Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

Time frame:: Baseline and Week 6.
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
percentage of participants	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg	56.5	57.8	48.7	48.8	22.3

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · Regression, Logistic · p = <0.001 (P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 4.98 · 95% CI 3.15 to 7.88
Azilsartan Medoxomil 40 mg QD vs Placebo QD · Regression, Logistic · p = <0.001 (P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 4.66 · 95% CI 2.94 to 7.37
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · Regression, Logistic · p = 0.032 (P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.45 · 95% CI 1.03 to 2.03
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · Regression, Logistic · p = 0.029 (P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.46 · 95% CI 1.04 to 2.06
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · Regression, Logistic · p = 0.080 (P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.35 · 95% CI 0.96 to 1.89
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · Regression, Logistic · p = 0.071 (P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.37 · 95% CI 0.97 to 1.92

SecondaryPercentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg

Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.

Time frame:: Baseline and Week 6.
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
percentage of participants	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg	68.8	71.1	63.8	68.2	43.9

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · Regression, Logistic · p = <0.001 (P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 3.29 · 95% CI 2.10 to 5.15
Azilsartan Medoxomil 40 mg QD vs Placebo QD · Regression, Logistic · p = <0.001 (P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 2.91 · 95% CI 1.86 to 4.54
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · Regression, Logistic · p = 0.306 (P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.22 · 95% CI 0.83 to 1.80
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · Regression, Logistic · p = 0.132 (P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.34 · 95% CI 0.92 to 1.97
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · Regression, Logistic · p = 0.695 (P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.08 · 95% CI 0.74 to 1.58
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · Regression, Logistic · p = 0.381 (P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.19 · 95% CI 0.81 to 1.74

SecondaryPercentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response

Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.

Time frame:: Baseline and Week 6.
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
percentage of participants	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response	49.1	52.6	43.9	44.5	18.2

Statistical analysis

Azilsartan Medoxomil 80 mg QD vs Placebo QD · Regression, Logistic · p = <0.001 (P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 5.18 · 95% CI 3.20 to 8.41
Azilsartan Medoxomil 40 mg QD vs Placebo QD · Regression, Logistic · p = <0.001 (P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 4.43 · 95% CI 2.73 to 7.19
Azilsartan Medoxomil 80 mg QD vs Olmesartan 40 mg QD · Regression, Logistic · p = 0.056 (P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.39 · 95% CI 0.99 to 1.94
Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD · Regression, Logistic · p = 0.036 (P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.44 · 95% CI 1.02 to 2.02
Azilsartan Medoxomil 40 mg QD vs Olmesartan 40 mg QD · Regression, Logistic · p = 0.317 (P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.19 · 95% CI 0.85 to 1.66
Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD · Regression, Logistic · p = 0.234 (P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.) · Odds ratio (or): 1.23 · 95% CI 0.87 to 1.73

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Azilsartan Medoxomil 40 mg QD	—	2/280 (0.7%)	18/280 (6.4%)
Azilsartan Medoxomil 80 mg QD	—	3/284 (1.1%)	12/284 (4.2%)
Valsartan 320 mg QD	—	3/277 (1.1%)	21/277 (7.6%)
Olmesartan 40 mg QD	—	4/290 (1.4%)	23/290 (7.9%)
Placebo QD	—	2/155 (1.3%)	14/155 (9%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
Abdominal adhesionsGastrointestinal disorders	0/280	0/284	0/277	0/290	1/155
FallInjury, poisoning and procedural complications	0/280	0/284	1/277	0/290	1/155
Intentional overdoseInjury, poisoning and procedural complications	0/280	0/284	1/277	0/290	0/155
Deep vein thrombosisVascular disorders	0/280	0/284	1/277	0/290	0/155
CholecystitisHepatobiliary disorders	1/280	0/284	0/277	0/290	0/155
Dysfunctional uterine bleedingReproductive system and breast disorders	1/280	0/284	0/277	0/290	0/155
CholelithiasisHepatobiliary disorders	1/280	0/284	0/277	0/290	0/155
Eye irritationEye disorders	0/280	1/284	0/277	0/290	0/155
Gastrointestinal haemorrhageGastrointestinal disorders	0/280	1/284	0/277	0/290	0/155
DiverticulitisInfections and infestations	0/280	1/284	0/277	0/290	0/155

Most frequent other events

Most frequent other events
Event	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD
HeadacheNervous system disorders	18/280	12/284	21/277	23/290	14/155

Baseline characteristics

Age Categorical
Age Categorical(participants)	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD	Total
<45 years	41	38	56	39	20	194
Between 45 and 64 years	170	184	178	185	98	815
≥65 years	69	63	48	66	36	282

Sex: Female, Male
Sex: Female, Male(Participants)	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Valsartan 320 mg QD	Olmesartan 40 mg QD	Placebo QD	Total
Female	133	134	130	131	64	592
Male	147	151	152	159	90	699

Study locations

131 sites

Alabaster, Alabama, United States
Ozark, Alabama, United States
Green Valley, Arizona, United States
Litchfield Park, Arizona, United States
Mesa, Arizona, United States
Tempe, Arizona, United States
Carmichael, California, United States
Chula Vista, California, United States
Lincoln, California, United States
Mission Viejo, California, United States
National City, California, United States
Pasadena, California, United States
Riverside, California, United States
Sacramento, California, United States
San Diego, California, United States
San Dimas, California, United States
San Fransisco, California, United States
San Ramon, California, United States
Santa Ana, California, United States
Vista, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Littleton, Colorado, United States
Longmont, Colorado, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
New Smyrna Beach, Florida, United States
Palm Harbor, Florida, United States
Tallahassee, Florida, United States
Dunwoody, Georgia, United States
Roswell, Georgia, United States
Arlington Heights, Illinois, United States
Belleville, Illinois, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Vernon Hills, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Terre Haute, Indiana, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Shawnee, Kansas, United States
Biddeford, Maine, United States
Norwood, Maine, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Brooklyn Center, Minnesota, United States
Chesterfield, Missouri, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Margate, New Jersey, United States
Glens Falls, New York, United States
Great Neck, New York, United States
New Hyde Park, New York, United States
New Windsor, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Columbus, Ohio, United States
Norman, Oklahoma, United States
Tulsa, Oklahoma, United States
Yukon, Oklahoma, United States
Ashland, Oregon, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Tipton, Pennsylvania, United States
Charleston, South Carolina, United States
Murrells Inlet, South Carolina, United States
North Charleston, South Carolina, United States
Cleveland, Tennessee, United States
Bedford, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Missouri City, Texas, United States
San Antonio, Texas, United States
Sugarland, Texas, United States
Tacoma, Washington, United States
Carlos Paz, Córdoba, Argentina
Guaymayen, Mendoza, Argentina
Bahía Blanca, Argentina
Berazategui, Argentina
Buenos Aires, Argentina
Corrientes, Argentina
Córdoba, Argentina
Haedo Pcia. de Buenos Aires, Argentina
Jujuy, Argentina
La Plata, Argentina
Ramos Mejía Pcia. de Buenos Aires, Argentina
Rosario, Argentina
Salta, Argentina
San Miguel de Tucumán, Argentina

Showing the first 100 of 131 sites across 6 countries.

References and documents

Publications

White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011 Mar;57(3):413-20. doi: 10.1161/HYPERTENSIONAHA.110.163402. Epub 2011 Jan 31. PubMed 21282560 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00696436
Lead sponsor: Takeda
First posted: Jun 12, 2008
Start date: Apr 2008
Primary completion: Aug 2009
Completion: Aug 2009
Results posted: Apr 19, 2011
Last update: Apr 19, 2011

Study contacts

Executive Medical Director Clinical Science

study director · Takeda

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.

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