Clinical trial No longer in our active list Phase 4 Interventional Ages 50 and up

Evaluating a new oral tablet for lowering cholesterol in patients with dyslipidemia

Official title: Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia

Run by Yonsei University · NCT06153433 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

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

PhasePhase 4
Study typeInterventional
Ages50 Years and up
SexAll
Enrollment112 (estimated)
SponsorYonsei University
Academic / other
Locations1 site (Seoul)
Trial IDNCT06153433 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown success with similar formulations of statins, indicating potential for this approach to be effective.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.