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

Last updated: November 22, 2023
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

4

Condition

Dyslipidemia

Treatment

Rosuvastatin Immediate-Release Tablet (IRT) 10mg

Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

Clinical Study ID

NCT06153433
4-2023-0589
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with dyslipidemia over 50 years of age who received statin treatmen for atleast 2 months
  2. Written informed consent to participate in the trial

Exclusion

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-galactosemalabsorption

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Phase: 4
Study Start date:
November 06, 2023
Estimated Completion Date:
August 31, 2024

Study 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

Connect with a study center

  • Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,

    Seoul,
    Korea, Republic of

    Active - Recruiting

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