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The purpose of this study is to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022
Condition or disease : Primary Hypercholesterolemia and Essential Hypertension Intervention/treatment Drug : AD-2021 Drug : AD-2022 Drug : AD-2021 Placebo Drug : AD-2022 Placebo Phase : Phase 3
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | AD-2021, AD-2022 |
|
| Active Comparator 1 | Active Comparator | AD-2021, AD-2022 placebo |
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| Active Comparator 2 | Active Comparator | AD-2022, AD-2021 placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-2021 | Drug | PO, Once daily(QD), 8weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022 | Baseline, Week 8 |
| Mean sitting systolic blood pressure (MSSBP) | MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021 | Baseline, Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seok Min Kang, M.D., Ph.D | Yonsei Cardiovascular Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cardiovascular Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| AD-2022 |
| Drug |
PO, Once daily(QD), 8weeks |
|
| AD-2021 Placebo | Drug | PO, Once daily(QD), 8weeks |
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| AD-2022 Placebo | Drug | PO, Once daily(QD), 8weeks |
|