Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
NCT ID: NCT06153433
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
112 participants
INTERVENTIONAL
2023-11-06
2024-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Rosuvastatin IR Tablet
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
SUVARO®OD Tablet
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Interventions
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Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent to participate in the trial
Exclusion Criteria
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
50 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Jung-Sun Kim
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity
Locations
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Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jung-Sun Kim
Role: primary
References
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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.
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.
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.
Other Identifiers
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4-2023-0589
Identifier Type: -
Identifier Source: org_study_id