HypercholesterolemiaPhase 4NCT01081548
A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia
A Phase 4 study testing atorvastatin in people with Hypercholesterolemia, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 20 ~ 79
- People who have not reached LDL-C targeted level in accordance with the guidelines for hyperlipidemia management released by Korean Society of Lipidology and Atherosclerosis
- In case of female participants taking combination HRT or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Lipinon® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia
The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.
- Conditions
- Hypercholesterolemia
- Being tested
- atorvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called Lipinon
20 mg
atorvastatinDrug
Also called Lipitor
20 mg
| Study group | Role | What they receive |
|---|---|---|
| Generic | Experimental | Not described Receives: Drug: atorvastatin |
| Lipitor | Active comparator | Not described Receives: Drug: atorvastatin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startAug 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.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081548
- Sponsor's protocol ID
- 4-2008-0288
- Status last verified
- Jan 2010
- First submitted
- 4 Mar 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Lipinon® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01081548
- Acronym / sponsor ID
- 4-2008-0288
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Mar 2010 (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.
The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic | Experimental | Drug: atorvastatin |
| Lipitor | Active comparator | Drug: atorvastatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20 ~ 79
- People who have not reached LDL-C targeted level in accordance with the guidelines for hyperlipidemia management released by Korean Society of Lipidology and Atherosclerosis
- In case of female participants taking combination HRT or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| atorvastatinAlso: Lipinon20 mg | Drug | Generic |
| atorvastatinAlso: Lipitor20 mg | Drug | Lipitor |
Primary outcome
Not reported in the source record.
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 5 Mar 2010.
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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 in people with Hypercholesterolemia, run by Yonsei University 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 3 inclusion and 0 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 5 Mar 2010. 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.
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 5 Mar 2010.