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

Study Overview
=================
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.

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

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

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg
* Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin IR Tablet<br>Rosuvastatin Immediate-Release Tablet (IRT) 10mg | Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg<br>* Rosuvastatin Immediate-Release Tablet (IRT) 10mg<br>|
| Experimental: SUVARO®OD Tablet<br>Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg | Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg<br>* Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyslipidemia, orally disintegrating tablet, odt, rosuvastatin, preference