DyslipidemiasNCT04829149
Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea
An observational study of Dyslipidemias, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Observational
- Type of treatment
- Pill or oral medicine
- How many people
- 5,717 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jun 2016to 29 Aug 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A Korean dyslipidemia patient who is taking or is scheduled to take statins therapy or Rosuzet tablets
Who may be able to join
- Age≥19
- Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab.
- Not diagnosed with diabetes
- Subject who can written informed consent voluntarily
- Subject can continue to participate for 12 months on Study
Who cannot join
- Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin)
- A pregnant or nursing woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
Read the detailed description
The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea
- Conditions
- Dyslipidemias
- Being tested
- Observational
- Keywords
- Statin, Rosuvastatin, New onset DM, LDL-C
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Statin therapy group and Rosuzet tablet group
| Study group | Role | What they receive |
|---|---|---|
| Statin therapy group (No interventional) | Observational. Statin therapy group: Once daily administered per the locally approved product information of rosuvastatin, simvastatin, atorvastatin, pitavastatin etc,. (except Rosuzet Tab.) Receives: Other: Observational | |
| Rosuzet tablet group (No interventional) | Observational. Rosuzet Tab.(ezetimibe/rosuvastatin) group: once daily administered per the locally approved product information of Rosuzet Tab. 10/5mg, 10/10mg, 10/20mg Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profiles
LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline
Measured: 12 months
Secondary outcomes (6)
Lipid profiles
LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline
Measured: 6 months
Lipid profiles
Triglyceride, HDL-C, Total Cholesterol percentage of change in Statin therapy group and Rosuzet group from baseline
Measured: 6, 12 months
Occurrence and aspect of new onset diabetes and adverse events
Occurrence and aspect of new onset diabetes and adverse events in Statin therapy group and Rosuzet group during the study period
Measured: 12 months
Prescription rate
Prescription rate of Statin therapy group and Rosuzet group during the study period
Measured: 12 months
Reason for medication change
Evaluation of Rate on reason for medication change in Statin therapy group and Rosuzet group during the study period
Measured: 12 months
Medication compliance
MPR(medication possession ratio) of Statin therapy group and Rosuzet group during the study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start14 Jun 2016
- Primary completion1 Jun 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mi-Jeung KIM, Study director, Hanmi Pharmaceutical Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829149
- Sponsor's protocol ID
- HM-ROZ-OS-01
- Status last verified
- Apr 2021
- First submitted
- 22 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
- ClinicalTrials.gov ID
- NCT04829149
- Acronym / sponsor ID
- HM-ROZ-OS-01
- Conditions
- Dyslipidemias
- Keywords
- Statin, Rosuvastatin, New onset DM, LDL-C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,717 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 2 Apr 2021 (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.
A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
Detailed description
The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin therapy group (No interventional) | – | Other: ObservationalObservational. Statin therapy group: Once daily administered per the locally approved product information of rosuvastatin, simvastatin, atorvastatin, pitavastatin etc,. (except Rosuzet Tab.) |
| Rosuzet tablet group (No interventional) | – | Other: ObservationalObservational. Rosuzet Tab.(ezetimibe/rosuvastatin) group: once daily administered per the locally approved product information of Rosuzet Tab. 10/5mg, 10/10mg, 10/20mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A Korean dyslipidemia patient who is taking or is scheduled to take statins therapy or Rosuzet tablets
Key inclusion criteria (5 listed)
- Age≥19
- Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab.
- Not diagnosed with diabetes
- Subject who can written informed consent voluntarily
- Subject can continue to participate for 12 months on Study
Key exclusion criteria (2 listed)
- Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin)
- A pregnant or nursing woman
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 |
|---|---|---|
| ObservationalStatin therapy group and Rosuzet tablet group | Other | Rosuzet tablet group (No interventional), Statin therapy group (No interventional) |
Primary outcome
Lipid profiles
Time frame: 12 months
LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline
6 secondary outcomes
Lipid profiles
Time frame: 6 months
Lipid profiles
Time frame: 6, 12 months
Occurrence and aspect of new onset diabetes and adverse events
Time frame: 12 months
Prescription rate
Time frame: 12 months
Reason for medication change
Time frame: 12 months
Medication compliance
Time frame: 12 months
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 2 Apr 2021.
- 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.
Mi-Jeung KIM study director
Hanmi Pharmaceutical Company Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by Hanmi Pharmaceutical Company Limited 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 5 inclusion and 2 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 2 Apr 2021. 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.
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?
Lipid profiles (time frame: 12 months). 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 2 Apr 2021.