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 74 investigative sites in Argentina, Chile, Mexico, Peru and the United States from 07 September 2007 to 05 March 2009.

Pre-Assignment Details

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

Reporting Groups

	Description
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg QD	Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.

Participant Flow:   Overall Study

	Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD	Chlorthalidone 25 mg QD
STARTED	185	182	184
COMPLETED	169	158	168
NOT COMPLETED	16	24	16
Adverse Event	9	9	6
Protocol Violation	2	3	0
Lost to Follow-up	1	4	1
Withdrawal by Subject	2	5	3
Lack of Efficacy	1	2	2
Other	1	1	4

Reporting Groups

	Description
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD	Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD	Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg QD	Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.

Baseline Measures

	Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD	Chlorthalidone 25 mg QD	Total
Number of Participants   [units: participants]	185	182	184	551
Age   [units: participants]
<45 years	21	15	16	52
Between 45 and 64 years	114	110	113	337
≥65 years	50	57	55	162
Gender   [units: participants]
Female	96	88	82	266
Male	89	94	102	285

1.  Primary:

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

2.  Secondary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

6.  Secondary:

Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

10.  Secondary:

Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

11.  Secondary:

Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

12.  Secondary:

Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

13.  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   [ Time Frame: Baseline and Week 6. ]

14.  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   [ Time Frame: Baseline and Week 6. ]

15.  Secondary:

Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.   [ Time Frame: Baseline and Week 6. ]