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

NCT ID: NCT02977065

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-23
• Study Completion Date: 2018-01-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atorvastatin 20 mg

To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks

Group Type: ACTIVE_COMPARATOR

Atorvastatin 20mg

Intervention Type: DRUG

PO daily for 4weeks

Atorvastatin 20 mg + CKD-519 50 mg

To administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks

Group Type: EXPERIMENTAL

Atorvastatin 20 mg + CKD-519 50 mg

Intervention Type: DRUG

PO daily for 4weeks

Atorvastatin 20 mg + CKD-519 100 mg

To administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks

Group Type: EXPERIMENTAL

Atorvastatin 20 mg + CKD-519 100 mg

Intervention Type: DRUG

PO daily for 4weeks

Atorvastatin 20 mg + CKD-519 200 mg

To administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks

Group Type: EXPERIMENTAL

Atorvastatin 20 mg + CKD-519 200 mg

Intervention Type: DRUG

PO daily for 4weeks

Rosuvastatin 10 mg

To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 10 mg

Intervention Type: DRUG

PO daily for 4weeks

Rosuvastatin 10 mg + CKD-519 100 mg

To administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks

Group Type: EXPERIMENTAL

Rosuvastatin 10 mg + CKD-519 100 mg

Intervention Type: DRUG

PO daily for 4weeks

Interventions

Atorvastatin 20mg

PO daily for 4weeks

Intervention Type: DRUG

Atorvastatin 20 mg + CKD-519 50 mg

PO daily for 4weeks

Intervention Type: DRUG

Atorvastatin 20 mg + CKD-519 100 mg

PO daily for 4weeks

Intervention Type: DRUG

Atorvastatin 20 mg + CKD-519 200 mg

PO daily for 4weeks

Intervention Type: DRUG

Rosuvastatin 10 mg

PO daily for 4weeks

Intervention Type: DRUG

Rosuvastatin 10 mg + CKD-519 100 mg

PO daily for 4weeks

Intervention Type: DRUG

Other Intervention Names

Lipitor 20mg; Lipitor 20mg; Lipitor 20mg; Lipitor 20mg; Crestor 10mg; Crestor 10mg

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 80 years.

2. Dyslipidemia with LDL-C

• At screening if untreated: 100 to 190 mg/dL
• At screening if treated with statins or other lipid-lowering drugs: 100 to 170 mg/dL
• At start of double-blind treatment: 100 to 190 mg/dL.

3. HDL-C <45 mg/dL (males) or <50 mg/dL (females).

4. Fasting TG <400 mg/dL.

5. Presence of the following conditions is permitted but not mandatory, at the discretion of the investigator:

• Treated and stable coronary heart disease without acute events in the past 3 months and stable, state-of-the-art medication.
• Treated and stable carotid artery disease or peripheral arterial disease on stable, standard medication for the past 3 months
• Treated and stable Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤9.5%.

6. Willing and able to sign the informed consent form (ICF).

Exclusion Criteria

1. Chronic heart failure as defined by New York Heart Association classes III and IV.

2. Uncontrolled cardiac arrhythmias.

3. Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1.

4. Stroke or transient ischemic attack within 3 months before Visit 1.

5. Uncontrolled hypertension.

6. Clinically significant laboratory abnormalities

• Aspartate aminotransferase or alanine aminotransferase >2 times upper limit of normal range
• Bilirubin >1.5 times upper limit of normal range
• Creatine kinase >2 times upper limit of normal range.

7. Any active nephropathy or estimated glomerular filtration rate <60 mL/min/1.73m2 or on kidney dialysis.

8. Poorly controlled (thyroid-stimulating hormone [TSH] >2 times upper limit of normal) hyperthyroidism.

9. Homozygous familial hypercholesterolemia.

10. Intolerance or hypersensitivity to atorvastatin or rosuvastatin.

11. Prior treatment with any CETP inhibitor.

12. Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Mi Park, PhD

Role: STUDY_DIRECTOR

Chong Kun Dang Pharm.

Locations

Not provided

Adelaide, , Australia

Countries

Australia

Other Identifiers

148HL16011

Identifier Type: -

Identifier Source: org_study_id