Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153433
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-11-22
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of SuvaroOD Tablet in Patients With Dyslipidemia
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Clinical Trial to Evaluate the Efficacy and Safety of SuvaroOD Tablet in Patients With Dyslipidemia
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of study is to evaluate the efficacy and safety of the new generic formulation rosuvastatin orally disintegrating tablet SUVAROODT 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 SUVAROODT in patients with dyslipidemia Also this study is designed to observe patients preference and adherence for SUVAROODT
HYPOTHESIS We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations SUVAROODT 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
HYPOTHESIS We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations SUVAROODT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None