Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Aliskiren / Ramipril / Amlodipine	6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Aliskiren /Amlodipine	6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Ramipril / Amlodipine	6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.

Participant Flow:   Overall Study

	Aliskiren / Ramipril / Amlodipine	Aliskiren /Amlodipine	Ramipril / Amlodipine
STARTED	61	60	57
COMPLETED	48	54	51
NOT COMPLETED	13	6	6
Adverse Event	10	4	5
Protocol Violation	1	1	0
Withdrawal by Subject	1	0	0
Administrative problems	1	1	1

Reporting Groups

	Description
Aliskiren / Ramipril / Amlodipine	6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Aliskiren /Amlodipine	6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Ramipril / Amlodipine	6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.

Baseline Measures

	Aliskiren / Ramipril / Amlodipine	Aliskiren /Amlodipine	Ramipril / Amlodipine	Total
Number of Participants   [units: participants]	61	60	57	178
Age   [units: years] Mean ± Standard Deviation	61.3  ± 8.90	58.3  ± 8.95	59.1  ± 8.86	59.6  ± 8.95
Age, Customized   [units: participants]
< 65 years	37	47	42	126
≥ 65 years	24	13	15	52
Gender   [units: participants]
Female	17	18	19	54
Male	44	42	38	124

1.  Primary:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)   [ Time Frame: Baseline to Week 12 ]

2.  Primary:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine   [ Time Frame: Baseline to Week 12 ]

4.  Secondary:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine   [ Time Frame: Baseline to Week 12 ]

5.  Secondary:

Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study   [ Time Frame: Week 12 ]

6.  Secondary:

Change in HOMA-IR From Baseline to End of Study   [ Time Frame: Baseline to Week 12 ]

7.  Secondary:

Change in HOMA-β From Baseline to End of Study   [ Time Frame: Baseline to Week 12 ]

8.  Secondary:

Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine   [ Time Frame: Baseline to Week 12 ]

9.  Secondary:

Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)   [ Time Frame: Baseline to Week 12 ]

10.  Secondary:

Percentage of Patients Who Developed Diabetes at End of Study   [ Time Frame: Week 12 ]