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
Among subjects who had completed the preceding study (A0531085, NCT00415623), where either Amlodipine 5 mg or 10 mg was administered for 8 weeks, those who were considered to be eligible for enrollment in this long-term study, based on safety and efficacy of the preceding study and who had a treatment compliance rate of at least 80% were enrolled.

Reporting Groups

	Description
Amlodipine	All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.

Participant Flow:   Overall Study

	Amlodipine
STARTED	134
COMPLETED	116
NOT COMPLETED	18
Adverse Event	16
Move	1
Withdrawal by Subject	1

Reporting Groups

	Description
Amlodipine	All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.

Baseline Measures

	Amlodipine
Number of Participants   [units: participants]	134
Age, Customized   [units: participants]
20 to 44 years	13
45 to 64 years	65
>=65 years	56
Gender   [units: participants]
Female	61
Male	73

1.  Primary:

Change in Systolic Blood Pressure From Baseline of the Preceding Study   [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

2.  Primary:

Change in Systolic Blood Pressure From Baseline of This Long-term Study   [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

3.  Primary:

Change in Diastolic Blood Pressure From Baseline of the Preceding Study   [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

4.  Primary:

Change in Diastolic Blood Pressure From Baseline of This Long-term Study   [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

5.  Primary:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value   [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

6.  Primary:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study   [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

7.  Other Pre-specified:

Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent   [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

8.  Other Pre-specified:

Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent   [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

9.  Other Pre-specified:

Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent   [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

10.  Other Pre-specified:

Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent   [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

11.  Other Pre-specified:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent   [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

12.  Other Pre-specified:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent   [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]