An Efficacy and Safety Study of Azilsartan Medoxomil Comp... | NCT00696436

ID	Type	Description	Link
U1111-1113-9161	Registry Identifier	WHO

Status Module

Description Module

Label	Type	Intervention Names
Azilsartan Medoxomil 40 mg QD	Experimental	Drug: Azilsartan medoxomil
Azilsartan Medoxomil 80 mg QD	Experimental	Drug: Azilsartan medoxomil
Valsartan 320 mg QD	Active Comparator	Drug: Valsartan
Olmesartan 40 mg QD	Active Comparator	Drug: Olmesartan
Placebo QD	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Azilsartan medoxomil	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and Week 6.

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline and Week 6.
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

Eligibility Module

Eligibility Criteria

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:

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.

Name	Affiliation	Role
Executive Medical Director Clinical Science	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
21282560	Result	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Azilsartan Medoxomil 40 mg QD	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.
FG001	Azilsartan Medoxomil 80 mg QD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Azilsartan Medoxomil 40 mg QD	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.
BG001	Azilsartan Medoxomil 80 mg QD	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.
BG002	Valsartan 320 mg QD	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.
BG003	Olmesartan 40 mg QD	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.
BG004	Placebo QD	Matching placebo, orally, once daily for up to six weeks.
BG005	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.
OG003	Olmesartan 40 mg QD	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.
OG004	Placebo QD	Matching placebo, orally, once daily for up to six weeks.

Units	Counts
Participants	OG000237 OG001229 OG002234 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-13.42± 0.690 OG001-14.53± 0.702 OG002-10.22± 0.696 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG004		ANCOVA		<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			2-Sided	95	-16.54	-12.01				No	Superiority or Other
OG000

Secondary

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.

Full analysis set with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full analysis set with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full Analysis Set.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full analysis set with last observation carried forward.

Posted

Number

percentage of participants

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full analysis set with last observation carried forward.

Posted

Number

percentage of participants

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD	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.

Secondary

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.

Full analysis set with last observation carried forward.

Posted

Number

percentage of participants

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 40 mg QD	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.
OG001	Azilsartan Medoxomil 80 mg QD	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.
OG002	Valsartan 320 mg QD

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Azilsartan Medoxomil 40 mg QD	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.	2	280	18	280
EG001	Azilsartan Medoxomil 80 mg QD	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.	3	284	12	284
EG002	Valsartan 320 mg QD	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.	3	277	21	277
EG003	Olmesartan 40 mg QD	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.	4	290	23	290
EG004	Placebo QD	Matching placebo, orally, once daily for up to six weeks.	2	155	14	155

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eye irritation	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected284 at risk EG0020 affected277 at risk EG0030 affected290 at risk EG0040 affected155 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected284 at risk EG0020 affected277 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected284 at risk EG0020 affected277 at risk EG003
Infected bites	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0021 affected277 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0021 affected277 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Blood pressure increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected284 at risk EG0020 affected277 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected280 at risk EG0010 affected284 at risk EG0021 affected277 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected284 at risk EG0020 affected277 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Alabaster	Alabama		United States

ID	Term
D006973	Hypertension
D000075222	Essential Hypertension
D002318	Cardiovascular Diseases

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D014633	Valine
D000597	Amino Acids, Branched-Chain
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000601	Amino Acids, Essential
D007093	Imidazoles

ID	Term
C557413	azilsartan medoxomil
C521273	azilsartan
D000068756	Valsartan
C437965	olmesartan
D000068557	Olmesartan Medoxomil