NCT06153433

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

November 22, 2023

Last Update Submit

November 22, 2023

Conditions

Dyslipidemia

Keywords

dyslipidemiaorally disintegrating tabletodtrosuvastatinpreference

Outcome Measures

Primary Outcomes (1)

  • Change in LDL-C level from Baseline after treatment of each formulation for 8 week

    Week 0, 8, 16

Secondary Outcomes (3)

  • Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week

    Week 0, 8, 16

  • Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week

    Week 0, 8, 16

  • Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week

    Week 0, 8, 16

Study Arms (2)

Rosuvastatin IR Tablet

ACTIVE COMPARATOR

Rosuvastatin Immediate-Release Tablet (IRT) 10mg

Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg

SUVARO®OD Tablet

EXPERIMENTAL

Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

Interventions

Rosuvastatin Immediate-Release Tablet (IRT) 10mgDRUG

Rosuvastatin Immediate-Release Tablet (IRT) 10mg

Rosuvastatin IR Tablet
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mgDRUG

Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

SUVARO®OD Tablet

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
  • Written informed consent to participate in the trial

You may not qualify if:

  • History of previous hypersensitivity reaction to other statins, including rosuvastatin
  • patients with acute arterial disease within 3 months
  • Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively
  • Uncontrolled diabetes mellitus (HbA1c \> 9%)
  • Uncontrolled hypothyroidism defined as TSH \>1.5 within the last 6 months
  • Taking other lipid lowering agent except statins
  • History of statin-induced myopathy, rhabdomyolysis
  • Patients with severe hepatic or renal dysfunction
  • BMI (body mass index) \> 40 kg/m2
  • history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,

Seoul, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 11524058BACKGROUND

  • 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.

    PMID: 30483816BACKGROUND

  • 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.

    PMID: 20195400BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jung-Sun Kim

    Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Sun Kim

CONTACT

+82-2-2228-8457kjs1218@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 1, 2023

Study Start

November 6, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)