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 DP-R207 in patients with primary hypercholesterolemia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin 5mg & Placebo & Placebo | Active Comparator | Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks |
|
| DP-R207 5/10mg & Placebo & Placebo | Experimental | Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks |
|
| Rosuvastatin 10mg & Placebo & Placebo | Active Comparator | Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks |
|
| DP-R207 10/10mg & Placebo & Placebo | Experimental | Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks |
|
| Rosuvastatin 20mg & Placebo & Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 5mg | Drug |
| ||
| DP-R207 5/10mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 8 weeks in LDL-Cholesterol | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 4 weeks in LDL-Cholesterol | baseline and 4 weeks | |
| Percent change from baseline to 4 weeks in lipid related blood test results | baseline and 4 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yangsoo Jang, Ph.D. | Severance Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seodaemun-gu | Seoul | 120-752 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Comparator |
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks |
|
| DP-R207 20/10mg & Placebo & Placebo | Experimental | Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks |
|
| Drug |
|
|
| Rosuvastatin 10mg | Drug |
|
| DP-R207 10/10mg | Drug |
|
|
| Rosuvastatin 20mg | Drug |
|
| DP-R207 20/10mg | Drug |
|
|
| Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) | Drug |
|
| Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) | Drug |
|
| Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) | Drug |
|
| Percent change from baseline to 8 weeks in lipid related blood test results |
| baseline and 8 weeks |
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline | week 4 and week 8 |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
Not provided
Not provided