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
Valsartan/Amlodipine 160/5 mg	Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Amlodipine 10 mg	Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.

Participant Flow:   Overall Study

	Valsartan/Amlodipine 160/5 mg	Amlodipine 10 mg
STARTED	592	591
COMPLETED	557	476
NOT COMPLETED	35	115
Adverse Event	15	84
Withdrawal by Subject	10	22
Protocol Violation	3	3
Lost to Follow-up	2	3
Administrative problems	2	1
Lack of Efficacy	2	1
Condition no longer requires study drug	1	1

Reporting Groups

	Description
Valsartan/Amlodipine 160/5 mg	Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Amlodipine 10 mg	Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.

Baseline Measures

	Valsartan/Amlodipine 160/5 mg	Amlodipine 10 mg	Total
Number of Participants   [units: participants]	592	591	1183
Age   [units: Age (years)] Mean ± Standard Deviation
Overall study	65.6  ± 7.56	65.4  ± 7.16	65.5  ± 7.36
Gender   [units: participants]
Female	285	284	569
Male	307	307	614

1.  Primary:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8   [ Time Frame: Baseline to Week 8 ]

2.  Primary:

Percentage of Patients With Peripheral Edema From Baseline to Week 8   [ Time Frame: Baseline to Week 8 ]

3.  Secondary:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8   [ Time Frame: Baseline to Week 8 ]

4.  Secondary:

Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12   [ Time Frame: Baseline to Weeks 4, 8, and 12 ]

5.  Secondary:

Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12   [ Time Frame: Baseline to Weeks 4, 8, and 12 ]