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

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06153433
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.8
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg; Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg	Phase 4

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
• Actual Study Start Date: Nov 6, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rosuvastatin IR Tablet Rosuvastatin Immediate-Release Tablet (IRT) 10mg	Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg; Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Experimental: SUVARO®OD Tablet Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg	Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg; Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

Outcome Measures

Primary Outcome Measures

1. Change in LDL-C level from Baseline after treatment of each formulation for 8 week [Week 0, 8, 16]

Secondary Outcome Measures

1. Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week [Week 0, 8, 16]

2. Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week [Week 0, 8, 16]

3. Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week [Week 0, 8, 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Jung-Sun Kim, Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT06153433
• Other Study ID Numbers: 4-2023-0589
• First Posted: Dec 1, 2023
• Last Update Posted: Dec 1, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yonsei University: dyslipidemia; orally disintegrating tablet; odt; rosuvastatin; preference
• Additional relevant MeSH terms: Dyslipidemias; Rosuvastatin Calcium

Study Results

No Results Posted as of Dec 1, 2023