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

NCT02977065 | Completed Phase 2

• 1 other identifier: 148HL16011
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Keywords

Dyslipidemia; CETP Inhibitors; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline (Visit 3) in LDL-C

  at Week 4

Secondary Outcomes (13)

• Percentage change from baseline in HDL-C

  at Weeks 2 and Week 4

• Percentage change from baseline in concentration of HDL particles (HDL-P)

  at Weeks 2 and 4

• Change from baseline in size of HDL particles (HDL-P)

  at Weeks 2 and 4

• Percentage change from baseline in LDL-C

  at Week 2

• Change in concentration from baseline in LDL-C

  at Weeks 2 and 4

Study Arms (6)

Atorvastatin 20 mg

ACTIVE COMPARATOR

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

Drug: Atorvastatin 20mg

Atorvastatin 20 mg + CKD-519 50 mg

EXPERIMENTAL

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

Drug: Atorvastatin 20 mg + CKD-519 50 mg

Atorvastatin 20 mg + CKD-519 100 mg

EXPERIMENTAL

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

Drug: Atorvastatin 20 mg + CKD-519 100 mg

Atorvastatin 20 mg + CKD-519 200 mg

EXPERIMENTAL

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

Drug: Atorvastatin 20 mg + CKD-519 200 mg

Rosuvastatin 10 mg

ACTIVE COMPARATOR

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

Drug: Rosuvastatin 10 mg

Rosuvastatin 10 mg + CKD-519 100 mg

EXPERIMENTAL

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

Drug: Rosuvastatin 10 mg + CKD-519 100 mg

Interventions

Atorvastatin 20mg DRUG

PO daily for 4weeks

Also known as: Lipitor 20mg

Atorvastatin 20 mg

Atorvastatin 20 mg + CKD-519 50 mg DRUG

PO daily for 4weeks

Also known as: Lipitor 20mg

Atorvastatin 20 mg + CKD-519 50 mg

Atorvastatin 20 mg + CKD-519 100 mg DRUG

PO daily for 4weeks

Also known as: Lipitor 20mg

Atorvastatin 20 mg + CKD-519 100 mg

Atorvastatin 20 mg + CKD-519 200 mg DRUG

PO daily for 4weeks

Also known as: Lipitor 20mg

Atorvastatin 20 mg + CKD-519 200 mg

Rosuvastatin 10 mg DRUG

PO daily for 4weeks

Also known as: Crestor 10mg

Rosuvastatin 10 mg

Rosuvastatin 10 mg + CKD-519 100 mg DRUG

PO daily for 4weeks

Also known as: Crestor 10mg

Rosuvastatin 10 mg + CKD-519 100 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years.
• 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.
• HDL-C \<45 mg/dL (males) or \<50 mg/dL (females).
• Fasting TG \<400 mg/dL.
• 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%.
• Willing and able to sign the informed consent form (ICF).

You may not qualify if:

• Chronic heart failure as defined by New York Heart Association classes III and IV.
• Uncontrolled cardiac arrhythmias.
• Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1.
• Stroke or transient ischemic attack within 3 months before Visit 1.
• Uncontrolled hypertension.
• 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.
• Any active nephropathy or estimated glomerular filtration rate \<60 mL/min/1.73m2 or on kidney dialysis.
• Poorly controlled (thyroid-stimulating hormone \[TSH\] \>2 times upper limit of normal) hyperthyroidism.
• Homozygous familial hypercholesterolemia.
• Intolerance or hypersensitivity to atorvastatin or rosuvastatin.
• Prior treatment with any CETP inhibitor.
• Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Not provided

Adelaide, Australia

Location

MeSH Terms

Conditions

Dyslipidemias; Hyperlipidemias

Interventions

Atorvastatin; CKD-519; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Kyung-Mi Park, PhD

  Chong Kun Dang Pharm.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: November 30, 2016
• Study Start: March 23, 2017
• Primary Completion: December 30, 2017
• Study Completion: January 30, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)