Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

Phase 3CompletedNCT02445352

Alvogen Korea379 enrolled

Overview

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

379

Conditions

Primary Hypercholesterolemia

Interventions

Rosuvastatin 5mgDRUG

DP-R207 5/10mgDRUG

Rosuvastatin 10mgDRUG

DP-R207 10/10mgDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital

Seodaemun-gu, Seoul, South Korea

Outcomes

Primary Outcomes

Percent change from baseline to 8 weeks in LDL-Cholesterol

Time frame: baseline and 8 weeks

Secondary Outcomes

Percent change from baseline to 4 weeks in LDL-Cholesterol

Time frame: baseline and 4 weeks

Percent change from baseline to 4 weeks in lipid related blood test results

Time frame: baseline and 4 weeks

Percent change from baseline to 8 weeks in lipid related blood test results

Time frame: baseline and 8 weeks

Percentage of patients reaching treatment goals according to NCEP ATP III Guideline

Time frame: week 4 and week 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.