NCT02262143已完成3 期
Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- The mean percent change of Non-HDL Cholesterol
研究概览
简要总结
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 ~ 80 years old
- •High risk patient to Coronary Heart Disease
- •At Visit 1(Screening)
- •Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
- •110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
- •At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
排除标准
- •AST or ALT > 2X ULN
- •Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN)
- •Patients with uncontrolled diabetes (HbA1c ≥ 9%)
- •Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
- •Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
- •Patients treated with any investigational drugs within 3 months at the time consents are obtained
- •Not eligible to participate for the study at the discretion of investigator
研究组 & 干预措施
Experimental
Experimental
Rosuvastatin 10 mg, Fenofibrate 160 mg
干预措施: Rosuvastatin (Drug)
Experimental
Experimental
Rosuvastatin 10 mg, Fenofibrate 160 mg
干预措施: Fenofibrate (Drug)
Comparator
Active Comparator
Rosuvastatin 10 mg
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
The mean percent change of Non-HDL Cholesterol
时间窗: from baseline at week 8
次要结局
- The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B(from baseline at week 4, 8)
- The mean change, percent change of Non-LDL-C(from baseline at week 4)
- The mean change of Non-LDL-C(from baseline at week 8)
- The achievement rate of Non-HDL-C<130mg/dl(from baseline at week 4, 8)
研究者
研究点 (1)
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