Clinical trial NCT06153433: Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
Official title: Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: dyslipidemia
orally disintegrating tablet
odt
rosuvastatin
preference
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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

Eligibility 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

Primary outcomes:
measure: Change in LDL-C level from Baseline after treatment of each formulation for 8 week
timeFrame: Week 0, 8, 16
Secondary outcomes:
measure: Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week
timeFrame: Week 0, 8, 16
measure: Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week
timeFrame: Week 0, 8, 16
measure: Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week
timeFrame: Week 0, 8, 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,
Study officials:
affiliation: Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity
name: Jung-Sun Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Zhang 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.
citation: Park 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.