DyslipidemiaPhase 4NCT01285544
The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia
A Phase 4 study testing Atorvastatin (Lipinon) and Atorvastatin (Lipitor) in people with Dyslipidemia and Cardiovascular Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Dyslipidemia, Cardiovascular Disease, Hypercholesterolemia
- What is being tested?
- Atorvastatin (Lipinon) and Atorvastatin (Lipitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Jul 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.
- Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C ≥100 mg/dl; patients with two or more risk factors and LDL-C≥130 mg/dl; patients with 0 or 1 risk factor and LDL-C >160 mg/dl after therapeutic lifestyle changes
Who cannot join
- therapy with any other investigational drug within 30 days of randomization,
- history of hypersensitivity to HMG-CoA reductase inhibitors,
- uncontrolled hypertension,
- poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >9%),
- unstable angina or presented with new-onset myocardial infarction (within 6 months),
- creatinine >2.5 mg/dl,
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- alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), aspartate aminotransferase(AST) >2 x ULN, or creatine kinase (CK) >2 x ULN,
- history of malignancy or psychosis;
- chronic liver disease,
- drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial
There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.
- Conditions
- Dyslipidemia, Cardiovascular Disease, Hypercholesterolemia
- Being tested
- Atorvastatin (Lipinon), Atorvastatin (Lipitor)
- Keywords
- statins, cholesterol, hypercholesterolemia, atorvastatin, Dyslipidemia in cardiovascular disease (KoLipinon)
- Medical subject headings
- Dyslipidemias, Cardiovascular Diseases, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin (Lipinon)Drug
treatment of dyslipidemia administration : PO, qod
Atorvastatin (Lipitor)Drug
treatment of dyslipidemia administration : PO, qod
| Study group | Role | What they receive |
|---|---|---|
| Lipinon-test formulation of atrovastain - 20mg | Experimental | Not described Receives: Drug: Atorvastatin (Lipinon) |
| Lipitor- branded formuation of atorvastatin-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.
the percent change of LDL-C level
Measured: After taken medication for 8 weeks
Secondary outcomes (1)
the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP)
Measured: After taken medication 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 posted28 Jan 2011 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285544
- Sponsor's protocol ID
- Lipinon Study
- Other IDs
- H-0807-056-251
- Status last verified
- Dec 2013
- First submitted
- 9 Jan 2011
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial. Clin Ther. 2013 Jan;35(1):77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub 2012 Dec 28.
PubMed 23274145
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial
- ClinicalTrials.gov ID
- NCT01285544
- Acronym / sponsor ID
- Lipinon Study
- Conditions
- Dyslipidemia, Cardiovascular Disease, Hypercholesterolemia
- Keywords
- statins, cholesterol, hypercholesterolemia, atorvastatin, Dyslipidemia in cardiovascular disease (KoLipinon)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Jan 2011 (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.
There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipinon-test formulation of atrovastain - 20mg | Experimental | Drug: Atorvastatin (Lipinon) |
| Lipitor- branded formuation of atorvastatin-20mg | Active comparator | Drug: Atorvastatin (Lipitor) |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.
- Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C ≥100 mg/dl; patients with two or more risk factors and LDL-C≥130 mg/dl; patients with 0 or 1 risk factor and LDL-C >160 mg/dl after therapeutic lifestyle changes
Key exclusion criteria (10 listed)
- therapy with any other investigational drug within 30 days of randomization,
- history of hypersensitivity to HMG-CoA reductase inhibitors,
- uncontrolled hypertension,
- poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >9%),
- unstable angina or presented with new-onset myocardial infarction (within 6 months),
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 (Lipinon)treatment of dyslipidemia administration : PO, qod | Drug | Lipinon-test formulation of atrovastain - 20mg |
| Atorvastatin (Lipitor)treatment of dyslipidemia administration : PO, qod | Drug | Lipitor- branded formuation of atorvastatin-20mg |
Primary outcome
the percent change of LDL-C level
Time frame: After taken medication for 8 weeks
1 secondary outcome
the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP)
Time frame: After taken medication 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 17 Dec 2013.
- Derived from this study: PubMed 23274145Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial. Clin Ther. 2013 Jan;35(1):77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub 2012 Dec 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin (Lipinon) and Atorvastatin (Lipitor) in people with Dyslipidemia and Cardiovascular Disease, run by Seoul National University Hospital 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 2 inclusion and 10 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 17 Dec 2013. 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 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?
the percent change of LDL-C level (time frame: After taken medication for 8 weeks). 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 NCT01285544, which also lists 1 linked publication.
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 17 Dec 2013.