Metabolic SyndromePhase 4NCT02940366
Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome
A Phase 4 study testing Pitavastatin 4 mg orally daily and Atorvastatin 20 mg orally daily in people with Metabolic Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pitavastatin 4 mg orally daily and Atorvastatin 20 mg orally daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2016to 30 Nov 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria
- Patients with hypercholesterolemia who required to start statin therapy
Who cannot join
- overt diabetes
- acute coronary syndrome within 2 months
- acute cerebrovascular event within 2 months
- recent treatment of statin within 1month
- recent diagnosed neoplasm
- recent diagnosed liver disease
Show all 12Show fewer
- chronic kidney disease
- patients with myopathy
- pregnant women, nursing mothers, women with possibility of pregnant
- patients being adminstered cyclosporine
- patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
- patients with treatment cyclosporin
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyung-Kwan Kim, MD, 82-2-2072-0243, cardiman73@gmail.com
Hyung-Kwan Kim, MD
About this study
Official title: the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial
This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Pitavastatin 4 mg orally daily, Atorvastatin 20 mg orally daily
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin 4 mg orally dailyDrug
Pitavastatin 4 mg orally daily for 24months
Atorvastatin 20 mg orally dailyDrug
Atorvastatin 20 mg orally daily for 24months
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 4 mg orally daily | Experimental | Not described Receives: Drug: Pitavastatin 4 mg orally daily |
| Atorvastatin 20 mg orally daily | Placebo comparator | Not described Receives: Drug: Atorvastatin 20 mg orally daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in HbA1c level
Measured: baselina and after 24months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
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 Metabolic SyndromeStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Principal investigator, Hyung-Kwan Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940366
- Sponsor's protocol ID
- 1406-027-584
- Status last verified
- Feb 2017
- First submitted
- 19 Oct 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
Publications
Park JB, Jung JH, Yoon YE, Kim HL, Lee SP, Kim HK, Kim YJ, Cho GY, Sohn DW. Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. Trials. 2017 Oct 27;18(1):501. doi: 10.1186/s13063-017-2229-4.
PubMed 29078817
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02940366
- Acronym / sponsor ID
- 1406-027-584
- Conditions
- Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 20 Oct 2016 (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.
This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 4 mg orally daily | Experimental | Drug: Pitavastatin 4 mg orally daily |
| Atorvastatin 20 mg orally daily | Placebo comparator | Drug: Atorvastatin 20 mg orally daily |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria
- Patients with hypercholesterolemia who required to start statin therapy
Key exclusion criteria (12 listed)
- overt diabetes
- acute coronary syndrome within 2 months
- acute cerebrovascular event within 2 months
- recent treatment of statin within 1month
- recent diagnosed neoplasm
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 |
|---|---|---|
| Pitavastatin 4 mg orally dailyPitavastatin 4 mg orally daily for 24months | Drug | Pitavastatin 4 mg orally daily |
| Atorvastatin 20 mg orally dailyAtorvastatin 20 mg orally daily for 24months | Drug | Atorvastatin 20 mg orally daily |
Primary outcome
Absolute change in HbA1c level
Time frame: baselina and after 24months treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 29078817Park JB, Jung JH, Yoon YE, Kim HL, Lee SP, Kim HK, Kim YJ, Cho GY, Sohn DW. Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. Trials. 2017 Oct 27;18(1):501. doi: 10.1186/s13063-017-2229-4.
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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.
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 Pitavastatin 4 mg orally daily and Atorvastatin 20 mg orally daily in people with Metabolic Syndrome, 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 12 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: status not confirmed, as of the sponsor's last update on 9 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in HbA1c level (time frame: baselina and after 24months treatment). 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 NCT02940366, 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 9 Feb 2017.