NCT03571087

Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

A Multi Center, Randomized, Double-blind, Parallel, Factorial Design, Therapeutic Phase III Study to Evaluate the Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.

Detailed description

The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe

Conditions

• Primary Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	HL140 5/10	1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ ●: HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab.5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
DRUG	HL140 10/10	1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ ○: HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
DRUG	HL140 20/10	1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
DRUG	Rosuvastatin 5mg → HL140 5/10	1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 5mg : ○♤♡■△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo,♡: HL140 20/10mg placebo, ■: Crestor Tab. 5mg, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo 2. Extension period(W9\~W20): 6Tab./q.d. HL1405/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ * HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
DRUG	Rosuvastatin 10mg → HL140 10/10	1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 10mg : ○♤♡□▲◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, ▲: Crestor Tab. 10mg, ◇: Crestor Tab. 20mg placebo 2. Extension period(W9\~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ * HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
DRUG	Rosuvastatin 20mg → HL140 20/10	1. Treatment(W0\~W8): 6Tab./q.d.Rosuvastatin 20mg : ○♤♡□△◆ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◆: Crestor Tab. 20mg 2. Extension period(W9\~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2018-06-27
• Last updated: 2018-08-14