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AzTrials

DyslipidemiasPhase 2NCT02977065

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

A Phase 2 study testing Atorvastatin 20mg, Atorvastatin 20 mg + CKD-519 50 mg and Atorvastatin 20 mg + CKD-519 100 mg in people with Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Dyslipidemias
What is being tested?
Atorvastatin 20mg, Atorvastatin 20 mg + CKD-519 50 mg and Atorvastatin 20 mg + CKD-519 100 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteAustralia
Study dates
23 Mar 2017to 30 Jan 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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).

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Not provided

    Adelaide

Other trials in Australia

About this study

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

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.

Read the 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
Being tested
Atorvastatin 20mg, Atorvastatin 20 mg + CKD-519 50 mg, Atorvastatin 20 mg + CKD-519 100 mg, Atorvastatin 20 mg + CKD-519 200 mg, Rosuvastatin 10 mg
Keywords
Dyslipidemia, CETP Inhibitors, Hyperlipidemia
Medical subject headings
Dyslipidemias, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 20mgDrug

    Also called Lipitor 20mg

    PO daily for 4weeks

  • Atorvastatin 20 mg + CKD-519 50 mgDrug

    Also called Lipitor 20mg

    PO daily for 4weeks

  • Atorvastatin 20 mg + CKD-519 100 mgDrug

    Also called Lipitor 20mg

    PO daily for 4weeks

  • Atorvastatin 20 mg + CKD-519 200 mgDrug

    Also called Lipitor 20mg

    PO daily for 4weeks

  • Rosuvastatin 10 mgDrug

    Also called Crestor 10mg

    PO daily for 4weeks

  • Rosuvastatin 10 mg + CKD-519 100 mgDrug

    Also called Crestor 10mg

    PO daily for 4weeks

Study groups in NCT02977065
Study groupRoleWhat they receive
Atorvastatin 20 mgActive comparatorTo administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks
Receives: Drug: Atorvastatin 20mg
Atorvastatin 20 mg + CKD-519 50 mgExperimentalTo administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks
Receives: Drug: Atorvastatin 20 mg + CKD-519 50 mg
Atorvastatin 20 mg + CKD-519 100 mgExperimentalTo administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks
Receives: Drug: Atorvastatin 20 mg + CKD-519 100 mg
Atorvastatin 20 mg + CKD-519 200 mgExperimentalTo administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks
Receives: Drug: Atorvastatin 20 mg + CKD-519 200 mg
Rosuvastatin 10 mgActive comparatorTo administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks
Receives: Drug: Rosuvastatin 10 mg
Rosuvastatin 10 mg + CKD-519 100 mgExperimentalTo administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks
Receives: Drug: Rosuvastatin 10 mg + CKD-519 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at Week 4

Secondary outcomes (13)

  1. Percentage change from baseline in HDL-C

    Measured: at Weeks 2 and Week 4

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

    Measured: at Weeks 2 and 4

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

    Measured: at Weeks 2 and 4

  4. Percentage change from baseline in LDL-C

    Measured: at Week 2

  5. Change in concentration from baseline in LDL-C

    Measured: at Weeks 2 and 4

  6. Change in concentration from baseline in HDL-C

    Measured: at Weeks 2 and 4

  7. Percentage change from baseline in total cholesterol, TG, and non-HDL-C

    Measured: at Weeks 2 and 4

  8. Change in concentration from baseline in total cholesterol, TG, and non-HDL-C

    Measured: at Weeks 2 and 4

  9. Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)

    Measured: at Weeks 2 and 4

  10. Change in concentration from baseline in Apo B, Apo A1, and Apo E

    Measured: at Weeks 2 and 4

  11. Percentage change from baseline in lipoprotein(a) (Lp-a)

    Measured: at Weeks 2 and 4

  12. Change in concentration from baseline in Lp-a

    Measured: at Weeks 2 and 4

  13. Change in concentration from baseline in high-sensitivity C-reactive protein at

    Measured: at Weeks 2 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2016 (estimated)
  2. Study start23 Mar 2017
  3. Primary completion30 Dec 2017
  4. Study completion30 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02977065
Sponsor's protocol ID
148HL16011
Status last verified
Nov 2018
First submitted
27 Nov 2016
Last updated
6 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atorvastatin 20mg, Atorvastatin 20 mg + CKD-519 50 mg and Atorvastatin 20 mg + CKD-519 100 mg in people with Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change from baseline (Visit 3) in LDL-C (time frame: at Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02977065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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