NCT02451098

Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

Detailed description

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Atorvastatin10mg, Ezetimibe10mg	Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
DRUG	Atorvastatin10mg, Ezetimibe placebo	Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
DRUG	Atorvastatin20mg, Ezetimibe10mg	Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
DRUG	Atorvastatin20mg, Ezetimibe placebo	Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
DRUG	Atorvastatin40mg, Ezetimibe10mg	Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
DRUG	Atorvastatin40mg, Ezetimibe placebo	Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2016-01-01
• First posted: 2015-05-21
• Last updated: 2016-01-28

Locations

1 site across 1 country: South Korea