Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty (20) centers in Japan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 301 subjects entered the 6-week diet observation period and the end of diet observation period, 165 subjects who met all the inclusion criteria for the treatment period and had no conflict to exclusion criteria were randomized to 4 CI-1038 groups.

Reporting Groups

	Description
CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Participant Flow:   Overall Study

	CI-1038 2.5 mg/5 mg	CI-1038 2.5 mg/10 mg	CI-1038 5 mg/5 mg	CI-1038 5 mg/10 mg
STARTED	43	41	41	40
COMPLETED	41	39	40	38
NOT COMPLETED	2	2	1	2
Adverse Event	1	2	1	1
Protocol Violation	0	0	0	1
Noncompliance	1	0	0	0

Reporting Groups

	Description
CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Baseline Measures

	CI-1038 2.5 mg/5 mg	CI-1038 2.5 mg/10 mg	CI-1038 5 mg/5 mg	CI-1038 5 mg/10 mg	Total
Number of Participants   [units: participants]	43	41	41	40	165
Age, Customized   [units: participants]
<20 years	0	0	0	0	0
20 to 44 years	8	3	4	5	20
45 to 64 years	20	21	23	23	87
>=65 years	15	17	14	12	58
Gender   [units: participants]
Female	23	28	25	22	98
Male	20	13	16	18	67
Region of Enrollment   [units: participants]
Japan	43	41	41	40	165

1.  Primary:

Change in Systolic Blood Pressure   [ 8 weeks ]

2.  Primary:

Percent Change in Low Density Lipoprotein-Cholesterol   [ 8 weeks ]

3.  Secondary:

Change in Systolic Blood Pressure From Baseline to Each Observation Point   [ 2 weeks, 4 weeks, and 8 weeks ]

4.  Secondary:

Change in Diastolic Blood Pressure From Baseline to Each Observation Point   [ 2 weeks, 4 weeks , and 8 weeks ]

5.  Secondary:

Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point   [ 2 weeks, 4 weeks , and 8 weeks ]

6.  Secondary:

Percent Change in Total Cholesterol From Baseline to Each Observation Point   [ 2 weeks, 4 weeks , and 8 weeks ]

7.  Secondary:

Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point   [ 2 weeks, 4 weeks , and 8 weeks ]

8.  Secondary:

Percent Change in Triglycerides From Baseline to Each Observation Point   [ 2 weeks, 4 weeks , and 8 weeks ]

9.  Secondary:

Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point   [ 2 weeks, 4 weeks, and 8 weeks ]

10.  Secondary:

Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point   [ 2 weeks, 4 weeks , and 8 weeks ]

11.  Secondary:

Change in Apolipoprotein B From Baseline to Each Observation Point   [ 2 weeks, 4 weeks, and 8 weeks ]