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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02977065
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: Atorvastatin 20mg Drug: Atorvastatin 20 mg + CKD-519 50 mg Drug: Atorvastatin 20 mg + CKD-519 100 mg Drug: Atorvastatin 20 mg + CKD-519 200 mg Drug: Rosuvastatin 10 mg Drug: Rosuvastatin 10 mg + CKD-519 100 mg Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : January 30, 2018

Arm Intervention/treatment
Active Comparator: Atorvastatin 20 mg
To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks
Drug: Atorvastatin 20mg
PO daily for 4weeks
Other Name: Lipitor 20mg

Experimental: Atorvastatin 20 mg + CKD-519 50 mg
To administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks
Drug: Atorvastatin 20 mg + CKD-519 50 mg
PO daily for 4weeks
Other Name: Lipitor 20mg

Experimental: Atorvastatin 20 mg + CKD-519 100 mg
To administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks
Drug: Atorvastatin 20 mg + CKD-519 100 mg
PO daily for 4weeks
Other Name: Lipitor 20mg

Experimental: Atorvastatin 20 mg + CKD-519 200 mg
To administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks
Drug: Atorvastatin 20 mg + CKD-519 200 mg
PO daily for 4weeks
Other Name: Lipitor 20mg

Active Comparator: Rosuvastatin 10 mg
To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks
Drug: Rosuvastatin 10 mg
PO daily for 4weeks
Other Name: Crestor 10mg

Experimental: Rosuvastatin 10 mg + CKD-519 100 mg
To administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks
Drug: Rosuvastatin 10 mg + CKD-519 100 mg
PO daily for 4weeks
Other Name: Crestor 10mg




Primary Outcome Measures :
  1. Percentage change from baseline (Visit 3) in LDL-C [ Time Frame: at Week 4 ]

Secondary Outcome Measures :
  1. Percentage change from baseline in HDL-C [ Time Frame: at Weeks 2 and Week 4 ]
  2. Percentage change from baseline in concentration of HDL particles (HDL-P) [ Time Frame: at Weeks 2 and 4 ]
  3. Change from baseline in size of HDL particles (HDL-P) [ Time Frame: at Weeks 2 and 4 ]
  4. Percentage change from baseline in LDL-C [ Time Frame: at Week 2 ]
  5. Change in concentration from baseline in LDL-C [ Time Frame: at Weeks 2 and 4 ]
  6. Change in concentration from baseline in HDL-C [ Time Frame: at Weeks 2 and 4 ]
  7. Percentage change from baseline in total cholesterol, TG, and non-HDL-C [ Time Frame: at Weeks 2 and 4 ]
  8. Change in concentration from baseline in total cholesterol, TG, and non-HDL-C [ Time Frame: at Weeks 2 and 4 ]
  9. Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E) [ Time Frame: at Weeks 2 and 4 ]
  10. Change in concentration from baseline in Apo B, Apo A1, and Apo E [ Time Frame: at Weeks 2 and 4 ]
  11. Percentage change from baseline in lipoprotein(a) (Lp-a) [ Time Frame: at Weeks 2 and 4 ]
  12. Change in concentration from baseline in Lp-a [ Time Frame: at Weeks 2 and 4 ]
  13. Change in concentration from baseline in high-sensitivity C-reactive protein at [ Time Frame: at Weeks 2 and 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977065


Locations
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Australia
Not provided
Adelaide, Australia
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Study Director: Kyung-Mi Park, PhD Chong Kun Dang Pharm.
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02977065    
Other Study ID Numbers: 148HL16011
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
Dyslipidemia
CETP Inhibitors
Hyperlipidemia
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors