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

NCT02977065 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-11-06

No results posted yet for this study

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.

Conditions

  • Dyslipidemias

Interventions

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

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Kyung-Mi Park, PhD · Chong Kun Dang Pharm.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2017-12-30
Completion
2018-01-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02977065 on ClinicalTrials.gov