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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977065
• Other study ID #: 148HL16011
• Status: Completed
• Phase: Phase 2
• Start date: March 23, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: November 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Atorvastatin 20mg
PO daily for 4weeks
• Atorvastatin 20 mg + CKD-519 50 mg
PO daily for 4weeks
• Atorvastatin 20 mg + CKD-519 100 mg
PO daily for 4weeks
• Atorvastatin 20 mg + CKD-519 200 mg
PO daily for 4weeks
• Rosuvastatin 10 mg
PO daily for 4weeks
• Rosuvastatin 10 mg + CKD-519 100 mg
PO daily for 4weeks

Locations

Country	Name	City	State
Australia	Not provided	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline (Visit 3) in LDL-C		at Week 4
Secondary	Percentage change from baseline in HDL-C		at Weeks 2 and Week 4
Secondary	Percentage change from baseline in concentration of HDL particles (HDL-P)		at Weeks 2 and 4
Secondary	Change from baseline in size of HDL particles (HDL-P)		at Weeks 2 and 4
Secondary	Percentage change from baseline in LDL-C		at Week 2
Secondary	Change in concentration from baseline in LDL-C		at Weeks 2 and 4
Secondary	Change in concentration from baseline in HDL-C		at Weeks 2 and 4
Secondary	Percentage change from baseline in total cholesterol, TG, and non-HDL-C		at Weeks 2 and 4
Secondary	Change in concentration from baseline in total cholesterol, TG, and non-HDL-C		at Weeks 2 and 4
Secondary	Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)		at Weeks 2 and 4
Secondary	Change in concentration from baseline in Apo B, Apo A1, and Apo E		at Weeks 2 and 4
Secondary	Percentage change from baseline in lipoprotein(a) (Lp-a)		at Weeks 2 and 4
Secondary	Change in concentration from baseline in Lp-a		at Weeks 2 and 4
Secondary	Change in concentration from baseline in high-sensitivity C-reactive protein at		at Weeks 2 and 4