HyperlipidemiaPhase 3NCT02451098
Clinical Trial to Evaluate the Efficacy and Safety of CKD-391
A Phase 3 study testing Atorvastatin10mg, Ezetimibe10mg, Atorvastatin20mg, Ezetimibe10mg and Atorvastatin40mg, Ezetimibe10mg in people with Hyperlipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Atorvastatin10mg, Ezetimibe10mg, Atorvastatin20mg, Ezetimibe10mg and Atorvastatin40mg, Ezetimibe10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Jan 2016
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, at least 19 years of age.
- Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
- Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]
- Drug compliance during Run-in period ≥70%
- Patients must willing to the study and signed an informed consent
Who cannot join
- Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
- Patients with acute arterial disease
- Patients with renal dysfunction or Serum creatinine level ≥2x ULN
- Patients with liver dysfunction or ALT, AST level > 2xULN
- Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
- Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN)
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- Patients who have a history or presence of active malignancy within 5 years
- Patients with difficulty of stop taking lipid-lowering agents during run-in period.
- Patients who have taken another investigational drug within 4 weeks prior to screening visit.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The catholic university of korea seoul st. Mary's hospital
Seoul
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.
Read the detailed description
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.
- Conditions
- Hyperlipidemia
- Being tested
- Atorvastatin10mg, Ezetimibe10mg, Atorvastatin10mg, Ezetimibe placebo, Atorvastatin20mg, Ezetimibe10mg, Atorvastatin20mg, Ezetimibe placebo, Atorvastatin40mg, Ezetimibe10mg
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin10mg, Ezetimibe10mgDrug
Also called CKD-391
Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
Atorvastatin10mg, Ezetimibe placeboDrug
Also called Lipitor
Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
Atorvastatin20mg, Ezetimibe10mgDrug
Also called CKD-391
Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
Atorvastatin20mg, Ezetimibe placeboDrug
Also called Lipitor
Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
Atorvastatin40mg, Ezetimibe10mgDrug
Also called CKD-391
Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
Atorvastatin40mg, Ezetimibe placeboDrug
Also called Lipitor
Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin10mg, Ezetimibe10mg | Experimental | Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks) Receives: Drug: Atorvastatin10mg, Ezetimibe10mg |
| Atorvastatin10mg, Ezetimibe placebo | Active comparator | Atorvastatin10mg, placebo will be administered (Duration 8 weeks) Receives: Drug: Atorvastatin10mg, Ezetimibe placebo |
| Atorvastatin20mg, Ezetimibe10mg | Experimental | Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks) Receives: Drug: Atorvastatin20mg, Ezetimibe10mg |
| Atorvastatin20mg, Ezetimibe placebo | Active comparator | Atorvastatin20mg, placebo will be administered (Duration 8 weeks) Receives: Drug: Atorvastatin20mg, Ezetimibe placebo |
| Atorvastatin40mg, Ezetimibe10mg | Experimental | Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks) Receives: Drug: Atorvastatin40mg, Ezetimibe10mg |
| Atorvastatin40mg, Ezetimibe placebo | Active comparator | Atorvastatin40mg, placebo will be administered (Duration 8 weeks) Receives: Drug: Atorvastatin40mg, Ezetimibe placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form baseline in LDL-C
Measured: up to week 8
Secondary outcomes (12)
Change form baseline in LDL-C
Measured: up to week 20
Change form baseline in Total cholesterol
Measured: up to week 20
Change form baseline in Triglyceride
Measured: up to week 20
Change form baseline in HDL-C
Measured: up to week 20
Change form baseline in Non-HDL-C
Measured: up to week 20
Change form baseline in LDL-C/HDL-C ratio
Measured: up to week 20
Change form baseline in TC/HDL-C ratio
Measured: up to week 20
Change form baseline in Non-HDL-C/HDL-C ratio
Measured: up to week 20
Change form baseline in Apo-B ratio
Measured: up to week 20
Change form baseline in Apo-B
Measured: up to week 20
Change form baseline in Apo-A1
Measured: up to week 20
Change form baseline in Apo-B/Apo-A1 ratio
Measured: up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ho-Jung Yoon, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451098
- Sponsor's protocol ID
- 152PDL14025
- Status last verified
- Jan 2016
- First submitted
- 18 May 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT02451098
- Acronym / sponsor ID
- 152PDL14025
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.
Detailed description
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin10mg, Ezetimibe10mg | Experimental | Drug: Atorvastatin10mg, Ezetimibe10mgAtorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks) |
| Atorvastatin10mg, Ezetimibe placebo | Active comparator | Drug: Atorvastatin10mg, Ezetimibe placeboAtorvastatin10mg, placebo will be administered (Duration 8 weeks) |
| Atorvastatin20mg, Ezetimibe10mg | Experimental | Drug: Atorvastatin20mg, Ezetimibe10mgAtorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks) |
| Atorvastatin20mg, Ezetimibe placebo | Active comparator | Drug: Atorvastatin20mg, Ezetimibe placeboAtorvastatin20mg, placebo will be administered (Duration 8 weeks) |
| Atorvastatin40mg, Ezetimibe10mg | Experimental | Drug: Atorvastatin40mg, Ezetimibe10mgAtorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks) |
| Atorvastatin40mg, Ezetimibe placebo | Active comparator | Drug: Atorvastatin40mg, Ezetimibe placeboAtorvastatin40mg, placebo will be administered (Duration 8 weeks) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult, at least 19 years of age.
- Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
- Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]
- Drug compliance during Run-in period ≥70%
- Patients must willing to the study and signed an informed consent
Key exclusion criteria (9 listed)
- Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
- Patients with acute arterial disease
- Patients with renal dysfunction or Serum creatinine level ≥2x ULN
- Patients with liver dysfunction or ALT, AST level > 2xULN
- Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin10mg, Ezetimibe10mgAlso: CKD-391Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks) | Drug | Atorvastatin10mg, Ezetimibe10mg |
| Atorvastatin10mg, Ezetimibe placeboAlso: LipitorAtorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks) | Drug | Atorvastatin10mg, Ezetimibe placebo |
| Atorvastatin20mg, Ezetimibe10mgAlso: CKD-391Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks) | Drug | Atorvastatin20mg, Ezetimibe10mg |
| Atorvastatin20mg, Ezetimibe placeboAlso: LipitorAtorvastatin20mg, Ezetimibe placebo(Duration: 8weeks) | Drug | Atorvastatin20mg, Ezetimibe placebo |
| Atorvastatin40mg, Ezetimibe10mgAlso: CKD-391Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks) | Drug | Atorvastatin40mg, Ezetimibe10mg |
| Atorvastatin40mg, Ezetimibe placeboAlso: LipitorAtorvastatin40mg, Ezetimibe placebo(Duration: 8weeks) | Drug | Atorvastatin40mg, Ezetimibe placebo |
Primary outcome
Change form baseline in LDL-C
Time frame: up to week 8
12 secondary outcomes
Change form baseline in LDL-C
Time frame: up to week 20
Change form baseline in Total cholesterol
Time frame: up to week 20
Change form baseline in Triglyceride
Time frame: up to week 20
Change form baseline in HDL-C
Time frame: up to week 20
Change form baseline in Non-HDL-C
Time frame: up to week 20
Change form baseline in LDL-C/HDL-C ratio
Time frame: up to week 20
Change form baseline in TC/HDL-C ratio
Time frame: up to week 20
Change form baseline in Non-HDL-C/HDL-C ratio
Time frame: up to week 20
Change form baseline in Apo-B ratio
Time frame: up to week 20
Change form baseline in Apo-B
Time frame: up to week 20
Change form baseline in Apo-A1
Time frame: up to week 20
Change form baseline in Apo-B/Apo-A1 ratio
Time frame: up to week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Jung Yoon, PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin10mg, Ezetimibe10mg, Atorvastatin20mg, Ezetimibe10mg and Atorvastatin40mg, Ezetimibe10mg in people with Hyperlipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 5 inclusion and 9 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 28 Jan 2016. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change form baseline in LDL-C (time frame: up to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2016.