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

Study Overview
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Brief Summary
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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

Official Title
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A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia

Conditions
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Hypertension, Hypercholesterolemia

Intervention / Treatment
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* Drug: Amlodipine 2.5mg/Atorvastatin 5mg
* Drug: Amlodipine 2.5mg/Atorvastatin 10mg
* Drug: Amlodipine 5mg/Atorvastatin 5mg
* Drug: Amlodipine 5mg/Atorvastatin 10mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CI-1038 2.5mg/5mg<br> | Drug: Amlodipine 2.5mg/Atorvastatin 5mg<br>* Single pill combination, dosed once daily for 8 weeks<br>|
| Active Comparator: CI-1038 2.5mg/10mg<br> | Drug: Amlodipine 2.5mg/Atorvastatin 10mg<br>* Single pill combination, dosed once daily for 8 weeks<br>|
| Active Comparator: CI-1038 5mg/5mg<br> | Drug: Amlodipine 5mg/Atorvastatin 5mg<br>* Single pill combination, dosed once daily for 8 weeks<br>|
| Active Comparator: CI-1038 5mg/10mg<br> | Drug: Amlodipine 5mg/Atorvastatin 10mg<br>* Single pill combination, dosed once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Value at Week 8 minus value at baseline | 8 weeks | 
| Percent Change in Low Density Lipoprotein-Cholesterol | Percent of value at Week 8 minus value at baseline over value at baseline | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure From Baseline to Each Observation Point | Value at Week 2, Week 4, or Week 8 minus value at baseline | 2 weeks, 4 weeks, and 8 weeks | 
| Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Value at Week 2, Week 4, or Week 8 minus value at baseline | 2 weeks, 4 weeks , and 8 weeks | 
| Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline | 2 weeks, 4 weeks , and 8 weeks | 
| Percent Change in Total Cholesterol From Baseline to Each Observation Point | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline | 2 weeks, 4 weeks , and 8 weeks | 
| Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline | 2 weeks, 4 weeks , and 8 weeks | 
| Percent Change in Triglycerides From Baseline to Each Observation Point | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline | 2 weeks, 4 weeks , and 8 weeks | 
| Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Value at Week 2, Week 4, or Week 8 minus value at baseline | 2 weeks, 4 weeks, and 8 weeks | 
| Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Value at Week 2, Week 4, or Week 8 minus value at baseline | 2 weeks, 4 weeks , and 8 weeks | 
| Change in Apolipoprotein B From Baseline to Each Observation Point | Value at Week 2, Week 4, or Week 8 minus value at baseline | 2 weeks, 4 weeks, and 8 weeks |