Overview

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

Status:
Recruiting

Trial end date:
2024-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yonsei University

Treatments:

Rosuvastatin Calcium

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