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 122 investigative sites in Bulgaria, Estonia, Finland, Germany, the Netherlands, Poland, Russia, Serbia and Montenegro, Slovakia and Sweden from 24 January 2008 to 21 April 2009.

Pre-Assignment Details

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

Reporting Groups

	Description
Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
Ramipril 10 mg QD	Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.

Participant Flow:   Overall Study

	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Ramipril 10 mg QD
STARTED	295	294	296
COMPLETED	265	264	255
NOT COMPLETED	30	30	41
Adverse Event	8	9	12
Protocol Violation	3	0	3
Lost to Follow-up	0	0	1
Withdrawal by Subject	12	14	13
Lack of Efficacy	3	2	4
Pregnancy	0	0	1
Physician Decision	1	1	1
Other	3	4	6

Reporting Groups

	Description
Azilsartan Medoxomil 40 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
Azilsartan Medoxomil 80 mg QD	Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
Ramipril 10 mg QD	Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.

Baseline Measures

	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Ramipril 10 mg QD	Total
Number of Participants   [units: participants]	295	294	295	884
Age   [units: Participants]
<45 years	40	45	30	115
Between 45 and 64 years	166	168	195	529
≥65 years	89	81	70	240
Gender   [units: participants]
Female	136	136	149	421
Male	159	158	146	463

1.  Primary:

Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.   [ Time Frame: Baseline and Week 24. ]

2.  Secondary:

Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure   [ Time Frame: Baseline and Week 24. ]

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring   [ Time Frame: Baseline and Week 24. ]

6.  Secondary:

Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring   [ Time Frame: Baseline and Week 24. ]

7.  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 24. ]

8.  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 24. ]

9.  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 24. ]

10.  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 24. ]

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 24. ]

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 24. ]