Primary Hypercholesterolemia
Conditions
Brief summary
The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.
Interventions
DRUGRosuvastatin 5mg
DRUGDP-R207 5/10mg
DRUGDP-R207 10/10mg
DRUGRosuvastatin 20mg
DRUGDP-R207 20/10mg
DRUGPlacebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
DRUGPlacebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
DRUGPlacebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Sponsors
Alvogen Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged over 19 years * Signed informed consent form * At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL
Exclusion criteria
* Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe * Liver transaminases \> 2 x upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to 8 weeks in LDL-Cholesterol | baseline and 8 weeks |
Secondary
| Measure | 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 |
| 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 |
Countries
South Korea
Outcome results
None listed