Efficacy and Safety of Azilsartan Medoxomil in Participan... | NCT00696241

ID	Type	Description	Link
U1111-1113-8905	Registry Identifier	WHO

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Azilsartan Medoxomil 20 mg QD	Experimental	Drug: Azilsartan medoxomil and olmesartan
Azilsartan Medoxomil 40 mg QD	Experimental	Drug: Azilsartan medoxomil and olmesartan
Azilsartan Medoxomil 80 mg QD	Experimental	Drug: Azilsartan medoxomil and olmesartan
Olmesartan 40 mg QD	Active Comparator	Drug: Olmesartan
Placebo QD	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azilsartan medoxomil and olmesartan	Drug	Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 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

Has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day minus 1) and 24-hour mean systolic blood pressure greater than or equal to 130 mm Hg and less than or equal to 170 mm Hg at Day 1).
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 (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
The subject is willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit. If the subject is on amlodipine prior to screening, the subject is willing to discontinue this medication at Screening Day minus 28.

Exclusion Criteria

Sitting trough clinic diastolic blood pressure greater than 114 mm Hg at Day minus 1.
Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
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 (eg, third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or atrial flutter).
Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Secondary hypertension of any etiology.
Is noncompliant (less than 70% or greater than 130%) with study medication during Placebo Run-In Period.
Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening.
Known or suspected unilateral or bilateral renal artery stenosis.
History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within the past 2 years.
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 subjects with basal cell or stage I squamous cell carcinoma of the skin).
Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening.
Alanine aminotransferase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
Hyperkalemia (defined as serum potassium greater than the upper limit of normal per the central laboratory) at Screening.
Upper arm circumference less than 24 cm or greater than 42 cm.
Works night (3rd) shift (defined as 11 PM to 7 AM).
Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Screening.
Any other serious disease or condition at Screening (or Randomization) that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.
Randomized in a previous azilsartan medoxomil study.

Name	Affiliation	Role
VP Clinical Science Strategy	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.
21272195

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
FG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
BG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
BG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
BG003	Olmesartan 40 mg QD	Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
BG004	Placebo QD	Placebo-matching tablets, orally, once daily for up to 6 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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD	Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
OG004	Placebo QD	Placebo-matching tablets, orally, once daily for up to 6 weeks.

Units	Counts
Participants	OG000241 OG001244 OG002243 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-12.15± 0.709 OG001-13.48± 0.704 OG002-14.62± 0.706 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
OG000 OG004		ANCOVA		<0.001	Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.	Mean Difference (Final Values)	-10.75				95	-13.17	-8.34				No	Superiority or Other
OG001 OG004

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 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD	Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
OG004	Placebo QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD	Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.

Secondary

Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure

The change in mean trough clinic sitting diastolic 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 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD	Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
OG004

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 6.

ID	Title	Description
OG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

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 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
OG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
OG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
OG003	Olmesartan 40 mg QD

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Azilsartan Medoxomil 20 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.	8	283	23	283
EG001	Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	0	281	19	281
EG002	Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	1	284	32	284
EG003	Olmesartan 40 mg QD	Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.	2	282	18	282
EG004	Placebo QD	Placebo-matching tablets, orally, once daily for up to 6 weeks.	3	142	13	142

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG0030 affected282 at risk EG0040 affected142 at risk
Coronary artery disease	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Chest pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Cellulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Pneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Epilepsy	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected283 at risk EG0010 affected281 at risk EG0021 affected284 at risk EG003
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Ischaemia	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003
Shock	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected283 at risk EG0010 affected281 at risk EG0020 affected284 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D006973	Hypertension
D000075222	Essential Hypertension
D002318	Cardiovascular Diseases

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment		EG00013 affected283 at risk EG0019 affected281 at risk EG00216 affected284 at risk EG0039 affected282 at risk EG00410 affected142 at risk
Dyslipidemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment		EG00010 affected283 at risk EG00111 affected281 at risk EG00216 affected284 at risk EG003

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