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The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.
In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-administered of AD-2071 and AD-2073 | Experimental | 48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks. |
|
| Co-administered of AD-2071 and AD-2072 | Active Comparator | 48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks. |
|
| AD-2073 | Active Comparator | 48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe/Rosuvastatin | Drug | PO, Once daily(QD), 8weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073 | Baseline, Week 8 |
| Mean sitting systolic blood pressure (MSSBP) | MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073 | Baseline, Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo Soo Kim, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| C548840 | telmisartan amlodipine combination |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Telmisartan | Drug | PO, Once daily(QD), 8weeks |
|
|
| Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET | Drug | PO, Once daily(QD), 8weeks |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013449 |
| Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |