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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02977065




Registration number
NCT02977065
Ethics application status
Date submitted
27/11/2016
Date registered
30/11/2016

Titles & IDs
Public title
To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors
Scientific 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
Secondary ID [1] 0 0
148HL16011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemias 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin 20mg
Treatment: Drugs - Atorvastatin 20 mg + CKD-519 50 mg
Treatment: Drugs - Atorvastatin 20 mg + CKD-519 100 mg
Treatment: Drugs - Atorvastatin 20 mg + CKD-519 200 mg
Treatment: Drugs - Rosuvastatin 10 mg
Treatment: Drugs - Rosuvastatin 10 mg + CKD-519 100 mg

Active comparator: Atorvastatin 20 mg - To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks

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

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

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

Active comparator: Rosuvastatin 10 mg - To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks

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


Treatment: Drugs: Atorvastatin 20mg
PO daily for 4weeks

Treatment: Drugs: Atorvastatin 20 mg + CKD-519 50 mg
PO daily for 4weeks

Treatment: Drugs: Atorvastatin 20 mg + CKD-519 100 mg
PO daily for 4weeks

Treatment: Drugs: Atorvastatin 20 mg + CKD-519 200 mg
PO daily for 4weeks

Treatment: Drugs: Rosuvastatin 10 mg
PO daily for 4weeks

Treatment: Drugs: Rosuvastatin 10 mg + CKD-519 100 mg
PO daily for 4weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change from baseline (Visit 3) in LDL-C
Timepoint [1] 0 0
at Week 4
Secondary outcome [1] 0 0
Percentage change from baseline in HDL-C
Timepoint [1] 0 0
at Weeks 2 and Week 4
Secondary outcome [2] 0 0
Percentage change from baseline in concentration of HDL particles (HDL-P)
Timepoint [2] 0 0
at Weeks 2 and 4
Secondary outcome [3] 0 0
Change from baseline in size of HDL particles (HDL-P)
Timepoint [3] 0 0
at Weeks 2 and 4
Secondary outcome [4] 0 0
Percentage change from baseline in LDL-C
Timepoint [4] 0 0
at Week 2
Secondary outcome [5] 0 0
Change in concentration from baseline in LDL-C
Timepoint [5] 0 0
at Weeks 2 and 4
Secondary outcome [6] 0 0
Change in concentration from baseline in HDL-C
Timepoint [6] 0 0
at Weeks 2 and 4
Secondary outcome [7] 0 0
Percentage change from baseline in total cholesterol, TG, and non-HDL-C
Timepoint [7] 0 0
at Weeks 2 and 4
Secondary outcome [8] 0 0
Change in concentration from baseline in total cholesterol, TG, and non-HDL-C
Timepoint [8] 0 0
at Weeks 2 and 4
Secondary outcome [9] 0 0
Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)
Timepoint [9] 0 0
at Weeks 2 and 4
Secondary outcome [10] 0 0
Change in concentration from baseline in Apo B, Apo A1, and Apo E
Timepoint [10] 0 0
at Weeks 2 and 4
Secondary outcome [11] 0 0
Percentage change from baseline in lipoprotein(a) (Lp-a)
Timepoint [11] 0 0
at Weeks 2 and 4
Secondary outcome [12] 0 0
Change in concentration from baseline in Lp-a
Timepoint [12] 0 0
at Weeks 2 and 4
Secondary outcome [13] 0 0
Change in concentration from baseline in high-sensitivity C-reactive protein at
Timepoint [13] 0 0
at Weeks 2 and 4

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/01/2018
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Not provided - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chong Kun Dang Pharmaceutical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kyung-Mi Park, PhD
Address 0 0
Chong Kun Dang Pharm.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02977065