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To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.
An efficacy and safety study of HCP1105 Capsule in combined hyperlipidemic patients with high risk for Coronary Heart Disease(CHD): A randomized,double-blind, multicenter, phase 3 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental sequence | Experimental | Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816 |
|
| comparative sequence | Placebo Comparator | Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1105 | Drug | Rosuvastatin + Omega-3-acids ethyl esters |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean rate of change of non-HDL-C (%) from baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean rate of change of HDL-C (%) from baseline | 4, 8, 12 weeks | |
| Mean rate of change of LDL-C (%) from baseline | 4, 8, 12 weeks | |
| Mean rate of change of Triglyceride (%) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang-Hee Jung | Contact | 02-3010-3246 | chjung0204@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jung-yeol Park, M.D., Ph.D. | Asan Medecal Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Euljii General Hospital | Recruiting | Seoul | Seoul | 139-711 | South Korea |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| HGP0816 |
| Drug |
Rosuvastatin |
|
| Placebo of HCP1105 | Drug | Soybean Oil |
|
| Placebo of HGP0816 | Drug | Exclusion of Rosuvastatin in HGP0816 |
|
| 4, 8, 12 weeks |
| Mean rate of change of Total cholesterol (%) from baseline | 4, 8, 12 weeks |
| Mean rate of change of Total apo A1 (%) from baseline | 4, 8, 12 weeks |
| Mean rate of change of Total apo B (%) from baseline | 4, 8, 12 weeks |
| Mean rate of change of Lipoprotein(a) (%) from baseline | 4, 8, 12 weeks |
| Mean rate of change of hs-CRP (%) from baseline | 4, 8, 12 weeks |
| Rate of the subjects who meet the target level of treatment | target level (Non-HDL-C<130mg/dL) | 4, 8, 12 weeks |