DyslipidemiaPhase 4NCT06153433
Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
A Phase 4 study testing Rosuvastatin Immediate-Release Tablet (IRT) 10mg and Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg in people with Dyslipidemia, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Rosuvastatin Immediate-Release Tablet (IRT) 10mg and Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2023to Aug 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
- Written informed consent to participate in the trial
Who cannot join
- History of previous hypersensitivity reaction to other statins, including rosuvastatin
- patients with acute arterial disease within 3 months
- Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively
- Uncontrolled diabetes mellitus (HbA1c > 9%)
- Uncontrolled hypothyroidism defined as TSH >1.5 within the last 6 months
- Taking other lipid lowering agent except statins
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- History of statin-induced myopathy, rhabdomyolysis
- Patients with severe hepatic or renal dysfunction
- BMI (body mass index) > 40 kg/m2
- history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,
Seoul
Jung-Sun Kim, +82-2-2228-8457, kjs1218@yuhs.ac
About this study
The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia.
Read the detailed description
STUDY OBJECTIVES: The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia. Also, this study is designed to observe patients' preference and adherence for SUVARO®ODT.
HYPOTHESIS: We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations (SUVARO®ODT 10-mg or rosuvastatin Immediate-release tablet (IR) 10-mg).
STUDY DESIGN: This is a randomized, multicenter, open-label, two-period crossover study with 112 enrolled patients.
Subjects: Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
- Conditions
- Dyslipidemia
- Being tested
- Rosuvastatin Immediate-Release Tablet (IRT) 10mg, Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
- Keywords
- dyslipidemia, orally disintegrating tablet, odt, rosuvastatin, preference
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin Immediate-Release Tablet (IRT) 10mgDrug
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mgDrug
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin IR Tablet | Active comparator | Rosuvastatin Immediate-Release Tablet (IRT) 10mg Receives: Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg |
| SUVARO®OD Tablet | Experimental | Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg Receives: Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-C level from Baseline after treatment of each formulation for 8 week
Measured: Week 0, 8, 16
Secondary outcomes (3)
Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week
Measured: Week 0, 8, 16
Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week
Measured: Week 0, 8, 16
Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week
Measured: Week 0, 8, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start6 Nov 2023
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Sun Kim, Principal investigator, Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153433
- Sponsor's protocol ID
- 4-2023-0589
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol. 2001 Sep 1;88(5):504-8. doi: 10.1016/s0002-9149(01)01727-1.
PubMed 11524058Zhang L, Zhang S, Yu Y, Jiang H, Ge J. Efficacy and safety of rosuvastatin vs. atorvastatin in lowering LDL cholesterol : A meta-analysis of trials with East Asian populations. Herz. 2020 Sep;45(6):594-602. doi: 10.1007/s00059-018-4767-2. Epub 2018 Nov 27.
PubMed 30483816Park JS, Kim YJ, Choi JY, Kim YN, Hong TJ, Kim DS, Kim KY, Jeong MH, Chae JK, Oh SK, Seong IW. Comparative study of low doses of rosuvastatin and atorvastatin on lipid and glycemic control in patients with metabolic syndrome and hypercholesterolemia. Korean J Intern Med. 2010 Mar;25(1):27-35. doi: 10.3904/kjim.2010.25.1.27. Epub 2010 Feb 26.
PubMed 20195400
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT06153433
- Acronym / sponsor ID
- 4-2023-0589
- Conditions
- Dyslipidemia
- Keywords
- dyslipidemia, orally disintegrating tablet, odt, rosuvastatin, preference
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 1 Dec 2023 (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 aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia.
Detailed description
STUDY OBJECTIVES: The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia. Also, this study is designed to observe patients' preference and adherence for SUVARO®ODT.
HYPOTHESIS: We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations (SUVARO®ODT 10-mg or rosuvastatin Immediate-release tablet (IR) 10-mg).
STUDY DESIGN: This is a randomized, multicenter, open-label, two-period crossover study with 112 enrolled patients.
Subjects: Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin IR Tablet | Active comparator | Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mgRosuvastatin Immediate-Release Tablet (IRT) 10mg |
| SUVARO®OD Tablet | Experimental | Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mgRosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
- Written informed consent to participate in the trial
Key exclusion criteria (10 listed)
- History of previous hypersensitivity reaction to other statins, including rosuvastatin
- patients with acute arterial disease within 3 months
- Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively
- Uncontrolled diabetes mellitus (HbA1c > 9%)
- Uncontrolled hypothyroidism defined as TSH >1.5 within the last 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 |
|---|---|---|
| Rosuvastatin Immediate-Release Tablet (IRT) 10mgRosuvastatin Immediate-Release Tablet (IRT) 10mg | Drug | Rosuvastatin IR Tablet |
| Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mgRosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg | Drug | SUVARO®OD Tablet |
Primary outcome
Change in LDL-C level from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
3 secondary outcomes
Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 11524058Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol. 2001 Sep 1;88(5):504-8. doi: 10.1016/s0002-9149(01)01727-1.
- Background: PubMed 30483816Zhang L, Zhang S, Yu Y, Jiang H, Ge J. Efficacy and safety of rosuvastatin vs. atorvastatin in lowering LDL cholesterol : A meta-analysis of trials with East Asian populations. Herz. 2020 Sep;45(6):594-602. doi: 10.1007/s00059-018-4767-2. Epub 2018 Nov 27.
- Background: PubMed 20195400Park JS, Kim YJ, Choi JY, Kim YN, Hong TJ, Kim DS, Kim KY, Jeong MH, Chae JK, Oh SK, Seong IW. Comparative study of low doses of rosuvastatin and atorvastatin on lipid and glycemic control in patients with metabolic syndrome and hypercholesterolemia. Korean J Intern Med. 2010 Mar;25(1):27-35. doi: 10.3904/kjim.2010.25.1.27. Epub 2010 Feb 26.
- 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.
Jung-Sun Kim principal investigator
Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity
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 Rosuvastatin Immediate-Release Tablet (IRT) 10mg and Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg in people with Dyslipidemia, 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 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Sun Kim (+82-2-2228-8457, kjs1218@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL-C level from Baseline after treatment of each formulation for 8 week (time frame: Week 0, 8, 16). 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 NCT06153433, which also lists 3 linked publications.
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 1 Dec 2023.