DyslipidemiaPhase 4KoLipilouNCT01029522
Dyslipidemia in Cardiovascular Disease
A Phase 4 study testing Atorvastatin (Lipilou) and Atorvastatin (Lipitor) in people with Dyslipidemia, run by Chong Kun Dang Pharmaceutical.
Trial summary
A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Atorvastatin (Lipilou) and Atorvastatin (Lipitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Nov 2009
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease
- diagnosed with atheroma in Coronary CT or Angiography, or SPECT positive or Treadmill test positive 2) Diabetes Mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) Peripheral artery disease
- Aged 20~85 years
- Volunteers consented with participating clinical trial and submitted consent paper
Who cannot join
- Experimental examination at screening 1) Active liver disease or more than 2 x ULN of AST/ALT 2) Creatine Kinase > 2 x ULN 3) Creatinine > 2.5mg/dL 4) Triglycerides > 500mg/dL
- intervened with stent in coronary artery disease less than 1 year before
- Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events
- Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
- As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL
- DBP > 100mmHg, SBP > 160mmHg
Show all 19Show fewer
- Diagnosed with myopathy
- Appear to be a risk of myopathy below
- renal impairment or prior renal dysfunction
- hypothyroidism
- genetic defects or family history of myopathy
- experienced prior muscle toxicity with taking statins or fibrates
- prior liver disease or higher intakes of alcohol
- aged over 70, and a risk of myopathy
- Women pregnant or breast-feeding
- Women capable of pregnancy without using contraceptives
- contra-indicated medically or mentally, or forbidden legally
- Enrolled to other clinical trial within 4 weeks
- Impossible to participate clinical trial according to investigator's decision
About this study
Official title: A Multi-center, Randomized, Double-blinded Equivalence Clinical Trial to Evaluate Efficacy and Safety of LipiLou 20 mg Versus Lipitor 20 mg in Hypercholesterolemic Patients With Higher Risk Cardiovascular Disease in Korea
A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.
- Conditions
- Dyslipidemia
- Being tested
- Atorvastatin (Lipilou), Atorvastatin (Lipitor)
- Keywords
- Dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin (Lipilou)Drug
treatment of dyslipidemia administration : PO, qod
Atorvastatin (Lipitor)Drug
Also called Lipitor
treatment of dyslipidemia administration : PO, qod
| Study group | Role | What they receive |
|---|---|---|
| Lipilou 20mg | Experimental | Not described Receives: Drug: Atorvastatin (Lipilou) |
| Lipitor 20mg | Active comparator | Not described Receives: Drug: Atorvastatin (Lipitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C
Measured: after taken medicine for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KIM hyo soo, ph D, Principal investigator, yongon-dong, jong-ro gu, Seoul National University Hospital, South of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029522
- Sponsor's protocol ID
- 224CHL08F
- Acronym
- KoLipilou
- Status last verified
- Aug 2012
- First submitted
- 16 Nov 2009
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blinded Equivalence Clinical Trial to Evaluate Efficacy and Safety of LipiLou 20 mg Versus Lipitor 20 mg in Hypercholesterolemic Patients With Higher Risk Cardiovascular Disease in Korea
- ClinicalTrials.gov ID
- NCT01029522
- Acronym / sponsor ID
- KoLipilou / 224CHL08F
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 Dec 2009 (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 multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipilou 20mg | Experimental | Drug: Atorvastatin (Lipilou) |
| Lipitor 20mg | Active comparator | Drug: Atorvastatin (Lipitor) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease
- Aged 20~85 years
- Volunteers consented with participating clinical trial and submitted consent paper
Key exclusion criteria (19 listed)
- Experimental examination at screening 1) Active liver disease or more than 2 x ULN of AST/ALT 2) Creatine Kinase > 2 x ULN 3) Creatinine > 2.5mg/dL 4) Triglycerides > 500mg/dL
- intervened with stent in coronary artery disease less than 1 year before
- Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events
- Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
- As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL
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 |
|---|---|---|
| Atorvastatin (Lipilou)treatment of dyslipidemia administration : PO, qod | Drug | Lipilou 20mg |
| Atorvastatin (Lipitor)Also: Lipitortreatment of dyslipidemia administration : PO, qod | Drug | Lipitor 20mg |
Primary outcome
LDL-C
Time frame: after taken medicine for 8 weeks
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 9 Aug 2012.
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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.
KIM hyo soo, ph D principal investigator
yongon-dong, jong-ro gu, Seoul National University Hospital, South of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin (Lipilou) and Atorvastatin (Lipitor) in people with Dyslipidemia, run by Chong Kun Dang Pharmaceutical.
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 4 inclusion and 19 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
LDL-C (time frame: after taken medicine for 8 weeks). 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 9 Aug 2012; AzTrials last refreshed its copy on 3 Nov 2026.