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

November 5, 2018 updated by: Chong Kun Dang Pharmaceutical

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Crestor 10mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage change from baseline (Visit 3) in LDL-C
Time Frame: at Week 4
at Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage change from baseline in HDL-C
Time Frame: at Weeks 2 and Week 4
at Weeks 2 and Week 4
Percentage change from baseline in concentration of HDL particles (HDL-P)
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Change from baseline in size of HDL particles (HDL-P)
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Percentage change from baseline in LDL-C
Time Frame: at Week 2
at Week 2
Change in concentration from baseline in LDL-C
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Change in concentration from baseline in HDL-C
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Percentage change from baseline in total cholesterol, TG, and non-HDL-C
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Change in concentration from baseline in total cholesterol, TG, and non-HDL-C
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
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
at Weeks 2 and 4
Change in concentration from baseline in Apo B, Apo A1, and Apo E
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Percentage change from baseline in lipoprotein(a) (Lp-a)
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Change in concentration from baseline in Lp-a
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4
Change in concentration from baseline in high-sensitivity C-reactive protein at
Time Frame: at Weeks 2 and 4
at Weeks 2 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kyung-Mi Park, PhD, Chong Kun Dang Pharm.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 148HL16011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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