Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 51 sites in the United States. Prime Therapy Period: April 2006 to February 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior antihypertensive medications were withdrawn/ tapered before patients entered the 4-week placebo run-in period.

Reporting Groups

	Description
Losartan	Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Placebo	Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg

Participant Flow:   Overall Study

	Losartan	Placebo
STARTED	127	134
COMPLETED	105	105
NOT COMPLETED	22	29
Adverse Event	3	3
Lack of Efficacy	3	11
Lost to Follow-up	3	3
Protocol Violation	3	1
Withdrawal by Subject	3	8
Unspecified	7	3

Reporting Groups

	Description
Losartan	Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Placebo	Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg

Baseline Measures

	Losartan	Placebo	Total
Number of Participants   [units: participants]	127	134	261
Age   [units: years] Mean ± Standard Deviation	50.1  ± 10.4	51.4  ± 9.7	50.8  ± 10.0
Gender   [units: participants]
Female	79	77	156
Male	48	57	105
Race/Ethnicity, Customized   [units: participants]
Caucasian	84	87	171
Black	22	29	51
Hispanic American	20	16	36
Native American	0	1	1
Other	1	1	2
Sitting Diastolic Blood Pressure (SiDBP)   [units: mm Hg] Mean ± Standard Deviation	99.1  ± 4.2	99.0  ± 4.0	99.0  ± 4.1
Sitting Systolic Blood Pressure (SiSBP)   [units: mm Hg] Mean ± Standard Deviation	151.6  ± 8.2	152.4  ± 9.0	152.0  ± 8.6

1.  Primary:

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8   [ Time Frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

2.  Primary:

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8   [ Time Frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

3.  Primary:

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12   [ Time Frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

4.  Primary:

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12   [ Time Frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

5.  Primary:

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16   [ Time Frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

6.  Primary:

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16   [ Time Frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]