Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient In: 12-Sep-2005 Last Patient In: 29-Dec-2006 Last Patient Last Visit: 31-Jan-08 Total number of Sites (General Practitioners and Family Physicians in Canada): 209

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 patients not included in the Intention to Treat (ITT) analysis because they did not receive study medication and had no follow up visits. Total ITT population = 1714.

Reporting Groups

	Description
Losartan +/- Hydrochlorothiazide	Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.

Participant Flow:   Overall Study

	Losartan +/- Hydrochlorothiazide
STARTED	1738
Week 4	1714
Week 8	1680
Week 12	1650
Week 32	1583
Week 52	1511
COMPLETED	1511
NOT COMPLETED	227
Adverse Event	47
Lost to Follow-up	144
Protocol Violation	9
Withdrawal by Subject	20
Non Compliance	7

Reporting Groups

	Description
Losartan +/- Hydrochlorothiazide	Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.

Baseline Measures

	Losartan +/- Hydrochlorothiazide
Number of Participants   [units: participants]	1714
Age   [units: Years] Mean ± Standard Deviation	54.93 ± 11.29
Age, Customized   [units: participants]
<=45.00	326
45.01 - 52.00	359
52.01 - 58.00	356
58.01 - 65.00	346
>=65.00	326
Missing	1
Gender   [units: participants]
Female	734
Male	980
Race/Ethnicity, Customized   [units: participants]
Caucasian	1451
Black	32
Asian	200
Native American	11
Other	19
Missing	1
Body Mass Index   [units: Kg/m2] Mean ± Standard Deviation	33.23 ± 5.59
C-Reactive Protein   [units: mg/L] Mean ± Standard Deviation	5.4 ± 8.8
Diastolic Blood Pressure   [units: mm Hg] Mean ± Standard Deviation	90.54 ± 8.16
Fasting Blood Glucose   [units: mmol/L] Mean ± Standard Deviation	5.7 ± 0.7
Heart Rate   [units: Beats per Minute (BPM)] Mean ± Standard Deviation	75 ± 8.0
Hemoglobin A1c   [units: Percent] Mean ± Standard Deviation	5.71 ± 0.59
High Density Lipoprotein-C   [units: mol/L] Mean ± Standard Deviation	1.23 ± 0.33
Low Density Lipoprotein-C   [units: mmol/L] Mean ± Standard Deviation	3.17 ± 0.93
Systolic Blood Pressure   [units: mm Hg] Mean ± Standard Deviation	148.22 ± 10.72
Total Cholesterol   [units: mmol/L] Mean ± Standard Deviation	5.36 ± 1.05
Triglycerides   [units: mmol/L] Mean ± Standard Deviation	2.16 ± 1.16
Uric Acid   [units: mmol/L] Mean ± Standard Deviation	365.8 ± 85.4
Weight   [units: Kilograms (Kg)] Mean ± Standard Deviation	92.5 ± 18.1

1.  Primary:

Change in Hemoglobin A1c Between 52 Weeks and Baseline   [ Time Frame: 52 Weeks - Baseline ]

2.  Primary:

Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments   [ Time Frame: 52 Weeks - Baseline ]

3.  Secondary:

Target Blood Pressure   [ Time Frame: 52 Weeks ]

4.  Secondary:

Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

5.  Secondary:

Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

6.  Other Pre-specified:

Change in Waist Circumference Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

7.  Other Pre-specified:

Change in Body Mass Index Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

8.  Other Pre-specified:

Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

9.  Other Pre-specified:

Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

10.  Other Pre-specified:

Percent Change in Triglycerides Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

11.  Other Pre-specified:

Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

12.  Other Pre-specified:

Absolute Change in Uric Acid Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

13.  Other Pre-specified:

Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]