HypercholesterolemiaPhase 4NCT04511000
Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg
A Phase 4 study testing Lipilou®(generic atorvastatin drug) 20 mg and Lipilou®(generic atorvastatin drug) 10 mg in people with Hypercholesterolemia, run by Chong Kun Dang Pharmaceutical at 10 sites in South Korea.
Trial summary
This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Lipilou®(generic atorvastatin drug) 20 mg and Lipilou®(generic atorvastatin drug) 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 11 Oct 2017to 20 May 2019
- Phase
- Phase 4
- 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
- Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.
Who cannot join
- Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
- Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Korea University Ansan Hospital
Ansan
Sejong General Hospital
Bucheon-si
Dong-A University Hospital
Busan
Inje University Ilsan Paik Hospital
Goyang
Myongji Hospital
Goyang
Seoul National University Bundang Hospital
Seongnam
Korea University Guro Hospital
Seoul
Ulsan University Hospital
Ulsan
Wonju Severance Christian Hospital
Wŏnju
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: A Randomized, Open-label, Parallel, Multi-Center Phase IV Study to Compare of the Efficacy and Safety of Lipilou 20 mg and Lipilou 10 mg in High-risk Patients With Hypercholesterolemia(PEARL Study)
This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.
- Conditions
- Hypercholesterolemia
- Being tested
- Lipilou®(generic atorvastatin drug) 20 mg, Lipilou®(generic atorvastatin drug) 10 mg
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipilou®(generic atorvastatin drug) 20 mgDrug
Patients assigned to experimental group are treated with Lipilou® 20 mg
Lipilou®(generic atorvastatin drug) 10 mgDrug
Patients assigned to comparator group are treated with Lipilou® 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Lipilou®(generic atorvastatin drug) 20 mg |
| Comparator group | Active comparator | Not described Receives: Drug: Lipilou®(generic atorvastatin drug) 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate in LDL-C
compare experimental group with comparator group
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start11 Oct 2017
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511000
- Sponsor's protocol ID
- 124HL17003
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel, Multi-Center Phase IV Study to Compare of the Efficacy and Safety of Lipilou 20 mg and Lipilou 10 mg in High-risk Patients With Hypercholesterolemia(PEARL Study)
- ClinicalTrials.gov ID
- NCT04511000
- Acronym / sponsor ID
- 124HL17003
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 12 Aug 2020 (actual)
- 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.
This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Lipilou®(generic atorvastatin drug) 20 mg |
| Comparator group | Active comparator | Drug: Lipilou®(generic atorvastatin drug) 10 mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.
Key exclusion criteria (2 listed)
- Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
- Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.
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 |
|---|---|---|
| Lipilou®(generic atorvastatin drug) 20 mgPatients assigned to experimental group are treated with Lipilou® 20 mg | Drug | Experimental group |
| Lipilou®(generic atorvastatin drug) 10 mgPatients assigned to comparator group are treated with Lipilou® 10 mg | Drug | Comparator group |
Primary outcome
Change rate in LDL-C
Time frame: 12 weeks of treatment
compare experimental group with comparator group
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 12 Aug 2020.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipilou®(generic atorvastatin drug) 20 mg and Lipilou®(generic atorvastatin drug) 10 mg in people with Hypercholesterolemia, run by Chong Kun Dang Pharmaceutical at 10 sites 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 1 inclusion and 2 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 rate in LDL-C (time frame: 12 weeks of treatment). 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 12 Aug 2020.