NCT02977065

To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors

Multicenter, Parallel-group, Double-blind, Randomized, Active-controlled, Dose-ranging Study to Assess the Safety, Efficacy, and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors, in Subjects With Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.

Detailed description

The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519, administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Atorvastatin 20mg	PO daily for 4weeks
DRUG	Atorvastatin 20 mg + CKD-519 50 mg	PO daily for 4weeks
DRUG	Atorvastatin 20 mg + CKD-519 100 mg	PO daily for 4weeks
DRUG	Atorvastatin 20 mg + CKD-519 200 mg	PO daily for 4weeks
DRUG	Rosuvastatin 10 mg	PO daily for 4weeks
DRUG	Rosuvastatin 10 mg + CKD-519 100 mg	PO daily for 4weeks

Timeline

• Start date: 2017-03-23
• Primary completion: 2017-12-30
• Completion: 2018-01-30
• First posted: 2016-11-30
• Last updated: 2018-11-06

Locations

1 site across 1 country: Australia