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The purpose of this study is to evaluate the efficacy and safety NVP-2203 in patients
This study is a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial to evaluate efficacy and safety of NVP-2203 in patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP-2203 | Experimental | NVP-2203 Plus other Placebo for up to 8 weeks, oral dose |
|
| NVP-2203-R1 | Active Comparator | NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose |
|
| NVP-2203-R2 | Active Comparator | NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose |
|
| NVP-2203-R3 | Active Comparator | NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-2203 | Drug | Take it once daily for 8 weeks orally. |
| |
| NVP-2203-R1 |
| Measure | Description | Time Frame |
|---|---|---|
| % change in LDL-C level from baseline | change in LDL-C level | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| % change in lipid panel from baseline | change in lipid panel | Week 4, 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HR Lim | Contact | +82-31-547-9781 | hrlim@nvp-healthcare.com | |
| AY Ji | Contact | +82-31-895-4636 | jay94@nvp-healthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| SH Lee, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NVPhealthcare | Recruiting | Suwon | Gyeonggi-do | 16209 | South Korea |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Drug |
Take it once daily for 8 weeks orally. |
|
| NVP-2203-R2 | Drug | Take it once daily for 8 weeks orally. |
|
| NVP-2203-R3 | Drug | Take it once daily for 8 weeks orally. |
|
| NVP-2203 Placebo | Drug | Take it once daily for 8 weeks orally. |
|
| NVP-2203-R1 Placebo | Drug | Take it once daily for 8 weeks orally. |
|
| NVP-2203-R2 Placebo | Drug | Take it once daily for 8 weeks orally. |
|
| NVP-2203-R3 Placebo | Drug | Take it once daily for 8 weeks orally. |
|