Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
NCT02445352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 379
Last updated 2015-05-15
Summary
The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.
Conditions
- Primary Hypercholesterolemia
Interventions
- DRUG
-
Rosuvastatin 5mg
- DRUG
-
DP-R207 5/10mg
- 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)
Sponsors & Collaborators
-
Alvogen Korea
lead INDUSTRY
Principal Investigators
-
Yangsoo Jang, Ph.D. · Severance Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2015-01-31
- Completion
- 2015-03-31
Countries
- South Korea
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