Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HGP0816 5mg | Active Comparator |
| |
| HGP0816 10mg | Active Comparator |
| |
| HGP0816 20mg | Active Comparator |
| |
| HCP1306 5/10mg | Experimental |
| |
| HCP1306 10/10mg | Experimental |
| |
| HCP1306 20/10mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGP0816 5mg | Drug | P.O. |
| |
| HGP0816 10mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 8 week in LDL-Cholesterol | baseline and 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 4 week in LDL-Cholesterol | baseline and 4 week | |
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline | week 4, week 8 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hyo-soo Kim, MD, Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 19 institutions including Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31727361 | Derived | Rhee MY, Kim KJ, Kim SH, Yoon YW, Rha SW, Hong SJ, Kwak CH, Kim W, Nam CW, Park TH, Hong TJ, Park S, Ahn Y, Lee N, Jeon HK, Jeon DW, Han KR, Moon KW, Chae IH, Kim HY, Kim HS. Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. Clin Ther. 2019 Dec;41(12):2571-2592. doi: 10.1016/j.clinthera.2019.10.010. Epub 2019 Nov 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
P.O. |
|
| HGP0816 20mg | Drug | P.O. |
|
| HCP1306 5/10mg | Drug | P.O. |
|
| HCP1306 10/10mg | Drug | P.O. |
|
| HCP1306 20/10mg | Drug | P.O. |
|
| Percent change from baseline to 4 week and 8 week in TC |
| week 4, week 8 |
| Percent change from baseline to 4 week and 8 week in HDL-C | week 4, week 8 |
| Percent change from baseline to 4 week and 8 week in TG | week 4, week 8 |