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

November 22, 2023 updated by: Yonsei University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in LDL-C level from Baseline after treatment of each formulation for 8 week
Time Frame: Week 0, 8, 16
Week 0, 8, 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week
Time Frame: Week 0, 8, 16
Week 0, 8, 16
Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week
Time Frame: Week 0, 8, 16
Week 0, 8, 16
Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week
Time Frame: Week 0, 8, 16
Week 0, 8, 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Estimated)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2023-0589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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