Evaluating a new oral tablet for lowering cholesterol in patients with dyslipidemia
Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
PHASE4 · Yonsei University · NCT06153433
This study is testing a new dissolvable cholesterol-lowering tablet to see if it works better and is preferred by people over 50 who have been taking statins for at least two months.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06153433 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of a new generic formulation of rosuvastatin in an orally disintegrating tablet form (SUVARO®ODT) for patients with dyslipidemia. The study is designed as a randomized, multicenter, open-label, two-period crossover trial involving 112 participants over the age of 50 who have been on statin treatment for at least two months. Researchers will compare the LDL-C lowering effects of SUVARO®ODT with those of the immediate-release rosuvastatin tablet while also observing patient preferences and adherence to the new formulation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 50 years old with dyslipidemia who have been on statin therapy for at least two months.
Not a fit: Patients with a history of hypersensitivity to statins, uncontrolled hypertension, diabetes, or severe hepatic or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more convenient and effective option for managing cholesterol levels in patients with dyslipidemia.
How similar studies have performed: Other studies have shown success with similar formulations of statins, indicating potential for this approach to be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months 2. Written informed consent to participate in the trial Exclusion Criteria: 1. History of previous hypersensitivity reaction to other statins, including rosuvastatin 2. patients with acute arterial disease within 3 months 3. Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively 4. Uncontrolled diabetes mellitus (HbA1c \> 9%) 5. Uncontrolled hypothyroidism defined as TSH \>1.5 within the last 6 months 6. Taking other lipid lowering agent except statins 7. History of statin-induced myopathy, rhabdomyolysis 8. Patients with severe hepatic or renal dysfunction 9. BMI (body mass index) \> 40 kg/m2 10. history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
Where this trial is running
Seoul
- Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity, — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Jung-Sun Kim — Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity
- Study coordinator: Jung-Sun Kim
- Email: kjs1218@yuhs.ac
- Phone: +82-2-2228-8457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyslipidemia, dyslipidemia, orally disintegrating tablet, odt, rosuvastatin, preference