Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in LDL-C level from Baseline after treatment of each formulation for 8 week
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rosuvastatin IR Tablet
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
干预措施: Rosuvastatin Immediate-Release Tablet (IRT) 10mg (Drug)
SUVARO®OD Tablet
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
干预措施: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg (Drug)
结局指标
主要结局
Change in LDL-C level from Baseline after treatment of each formulation for 8 week
时间窗: Week 0, 8, 16
次要结局
- 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)
- Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week(Week 0, 8, 16)