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To Evaluate the Efficacy and Safety of CKD-333
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental | Patients assigned to this group are treated with CKD-330, D086 |
|
| Placebo Group 1 | Placebo Comparator | Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086) |
|
| Placebo Group 2 | Placebo Comparator | Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-330 | Drug | CKD-330 Tab. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change rate from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 8 weeks after drug administrations |
| Change from baseline in MSSBP | Compare experimental group 1 with placebo group 2 | 8 weeks after drug administrations |
| Measure | Description | Time Frame |
|---|---|---|
| Change rate from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 4 weeks after drug administrations |
| Change from baseline in LDL-C | Compare experimental group 1 with placebo group 1 |
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Inclusion Criteria:
Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period
Lipid levels measured after run-in period were:
Exclusion Criteria:
Patients whose blood pressures measured at Visit 2 were:
Patients who had lipid levels measured at Visit 2
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | South Korea | ||||
| Pusan National University Hospital |
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| Placebo of CKD-330 |
| Drug |
Placebo of CKD-330 Tab. |
|
| D086 | Drug | D086 Tab. |
|
| Placebo of D086 | Drug | Placebo of D086 Tab. |
|
| D723 | Drug | D723 Tab. |
|
| Placebo of D723 | Drug | Placebo of D723 Tab. |
|
| 4, 8 weeks after drug administrations |
| Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |
| Change from baseline in MSSBP(mmHg) | Compare experimental group 1 with placebo group 2 | 4 weeks after drug administrations |
| Change from baseline in MSDBP | Compare experimental group 1 with placebo group 2 | 4, 8 weeks after drug administrations |
| Attainment of normal blood pressure as defined by JNC Ⅶ | Compare experimental group 1 with placebo group 2 | 4, 8 weeks after drug administrations |
| Change from baseline in TC | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |
| Change from baseline in TG | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |
| Change from baseline in HDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |
| change rate from baseline in TC | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |
| change rate from baseline in TG | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |
| change rate from baseline in HDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |
| Busan |
| South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Gachon University Gil Hospital | Incheon | South Korea |
| Catholic University Seoul St. Mary's Hospital | Seoul | South Korea |
| Hanyang University Hospital | Seoul | South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyunghee University Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul Asan Medical Center | Seoul | South Korea |
| Seoul Medical Center | Seoul | South Korea |
| Yonsei University Medical Center Gangnam Severance Hospital | Seoul | South Korea |
| Yonsei University Medical Center Severance Hospital | Seoul | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |