A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

• Change in Systolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Percent Change in Low Density Lipoprotein-Cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

• Change in Systolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
• Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
• Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
• Percent Change in Total Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
• Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
• Percent Change in Triglycerides From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
• Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
• Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
• Change in Apolipoprotein B From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]

• 1.The changes in the following efficacy endpoints from baseline to each visit: SBP (except that at Week 8), DBP, LDL-C (except that at Week 8), TC, HDL-C, TG, LDL-C/HDL-C ratio, TC/HDL-C ratio and ApolipoproteinB.
• 2. Safety endpoints (Adverse events, laboratory tests, 12-lead ECG, pulse rate)

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

• Hypertension
• Hypercholesterolemia

• Drug: Amlodipine 2.5mg/Atorvastatin 5mg
  Single pill combination, dosed once daily for 8 weeks
• Drug: Amlodipine 2.5mg/Atorvastatin 10mg
  Single pill combination, dosed once daily for 8 weeks
• Drug: Amlodipine 5mg/Atorvastatin 5mg
  Single pill combination, dosed once daily for 8 weeks
• Drug: Amlodipine 5mg/Atorvastatin 10mg
  Single pill combination, dosed once daily for 8 weeks

• Active Comparator: CI-1038 2.5mg/5mg
  Intervention: Drug: Amlodipine 2.5mg/Atorvastatin 5mg
• Active Comparator: CI-1038 2.5mg/10mg
  Intervention: Drug: Amlodipine 2.5mg/Atorvastatin 10mg
• Active Comparator: CI-1038 5mg/5mg
  Intervention: Drug: Amlodipine 5mg/Atorvastatin 5mg
• Active Comparator: CI-1038 5mg/10mg
  Intervention: Drug: Amlodipine 5mg/Atorvastatin 10mg

Inclusion Criteria:

• The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
• The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
• LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Exclusion Criteria:

• Subjects who had experienced the following coronary artery disease within the past 3 months.
• Myocardial infarction
• Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
• Any clinically meaningful valvular disease
• Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.