Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled at 66 investigative sites in the Russian Federation and the United States from 20 January 2009 to 30 November 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with patients with moderate to severe essential hypertension were enrolled in one of 2, once-daily (QD) treatment groups.

Reporting Groups

	Description
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.

Participant Flow:   Overall Study

	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
STARTED	303	306
COMPLETED	252	260
NOT COMPLETED	51	46
Adverse Event	28	19
Protocol Violation	2	2
Lost to Follow-up	3	2
Withdrawal by Subject	16	14
Lack of Efficacy	0	2
Other	2	7

Reporting Groups

	Description
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.

Baseline Measures

	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD	Total
Number of Participants   [units: participants]	303	306	609
Age   [units: years] Mean ± Standard Deviation	56.8  ± 10.79	55.9  ± 10.97	56.4  ± 10.88
Age, Customized   [units: participants]
<45 years	43	50	93
Between 45 and 64 years	189	195	384
≥65 years	71	61	132
Gender   [units: participants]
Female	158	155	313
Male	145	151	296
Ethnicity (NIH/OMB)   [units: participants]
Hispanic or Latino	40	28	68
Not Hispanic or Latino	173	184	357
Unknown or Not Reported	90	94	184
Race (NIH/OMB) [1] [units: participants]
American Indian or Alaska Native	6	1	7
Asian	3	2	5
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	46	38	84
White	252	265	517
More than one race	5	0	5
Unknown or Not Reported	0	0	0
Region of Enrollment   [units: participants]
United States	213	214	427
Russian Federation	90	92	182
Estimated glomerular filtration rate (eGFR) [2] [units: participants]
Moderate impairment	23	24	47
Mild impairment	180	184	364
Normal	100	98	198
Weight   [units: kg] Mean ± Standard Deviation	87.60  ± 19.181	90.61  ± 19.252	89.11  ± 19.260
Height   [units: cm] Mean ± Standard Deviation	168.9  ± 10.08	168.8  ± 9.69	168.9  ± 9.88
Body Mass Index (BMI)   [units: kg/m2] Median ± Standard Deviation	30.7  ± 6.12	31.8  ± 6.10	31.2  ± 6.13
Chronic Kidney Disease (CKD) Status [3] [units: participants]	24	24	48
Diabetes status   [units: participants]	31	35	66

1.  Primary:

Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure   [ Time Frame: Baseline, Week 6 and Week 10. ]

2.  Secondary:

Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure   [ Time Frame: Baseline, Week 6 and Week 10. ]

3.  Secondary:

Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

4.  Secondary:

Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

5.  Secondary:

Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

6.  Secondary:

Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

7.  Secondary:

Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

8.  Secondary:

Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

9.  Secondary:

Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

10.  Secondary:

Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

11.  Secondary:

Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring   [ Time Frame: Baseline, Week 6 and Week 10. ]

12.  Secondary:

Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline, Week 6 and Week 10. ]

13.  Secondary:

Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease   [ Time Frame: Week 2, Week 4, Week 6, Week 8 and Week 10. ]

14.  Secondary:

Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.   [ Time Frame: Week 2, Week 4, Week 6, Week 8 and Week 10. ]

15.  Secondary:

Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease   [ Time Frame: Week 2, Week 4, Week 6, Week 8 and Week 10. ]