HypercholesterolemiaPROOFNCT04402112
Efficacy and Safety of Pitavastatin in a Real-world Setting
An observational study of Hypercholesterolemia, run by JW Pharmaceutical.
Trial summary
The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Pitavastatin
- How many people
- 28,343 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2012to 1 Aug 2017
- Phase
- Observational
- 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
Study population: Patients receiving Livalo tablets in clinical practice in South Korea
Who may be able to join
- Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.
Who cannot join
- Patients with hypersensitivity to pitavastatin
- Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in
- Patients with severe liver failure or biliary obstruction and patients with cholestasis
- Patients who are receiving cyclosporine
- Myopathy patients
- Pregnant women or women of childbearing age and lactating women
Show all 9Show fewer
- Children
- Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose
- Patients deemed inappropriate by the investigator
About this study
Official title: Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea
The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.
Read the detailed description
This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Pitavastatin
- Keywords
- Pitavastatin, LIVALO, Safety data, South Korea, Large-scale prospective trial
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Also called LIVALO
1mg, 2mg, or 4mg, Once a day, at least 8 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by CTCAE v4.0
Incidence of musculoskeletal-related adverse events and rhabdomyolysis
Measured: At 8 weeks after administration of pitavastatin
Secondary outcomes (2)
Overall symptom satisfaction evaluation
The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation
Measured: At 8 weeks after administration of pitavastatin
Change in serum lipid profile before and after administration of pitavastatin
Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride
Measured: At screening and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start2 Apr 2012
- Primary completion1 Apr 2017
- Study completion1 Aug 2017
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 HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28,343 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Rae Kim, MD,PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402112
- Sponsor's protocol ID
- JWP-PTV-712
- Acronym
- PROOF
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2.
PubMed 33261312
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea
- ClinicalTrials.gov ID
- NCT04402112
- Acronym / sponsor ID
- PROOF / JWP-PTV-712
- Conditions
- Hypercholesterolemia
- Keywords
- Pitavastatin, LIVALO, Safety data, South Korea, Large-scale prospective trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,343 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2012 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 26 May 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.
The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.
Detailed description
This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving Livalo tablets in clinical practice in South Korea
Key inclusion criteria (1 listed)
- Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.
Key exclusion criteria (9 listed)
- Patients with hypersensitivity to pitavastatin
- Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in
- Patients with severe liver failure or biliary obstruction and patients with cholestasis
- Patients who are receiving cyclosporine
- Myopathy patients
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 |
|---|---|---|
| PitavastatinAlso: LIVALO1mg, 2mg, or 4mg, Once a day, at least 8 weeks | Drug | – |
Primary outcome
Number of participants with adverse events as assessed by CTCAE v4.0
Time frame: At 8 weeks after administration of pitavastatin
Incidence of musculoskeletal-related adverse events and rhabdomyolysis
2 secondary outcomes
Overall symptom satisfaction evaluation
Time frame: At 8 weeks after administration of pitavastatin
Change in serum lipid profile before and after administration of pitavastatin
Time frame: At screening and after 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 19 Apr 2021.
- Results publication: PubMed 33261312Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2.
- Individual participant dataSharing planned: No
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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.
Sung-Rae Kim, MD,PhD principal investigator
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by JW 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 1 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 19 Apr 2021. 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.
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?
Number of participants with adverse events as assessed by CTCAE v4.0 (time frame: At 8 weeks after administration of pitavastatin). 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 NCT04402112, 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 19 Apr 2021.