A Randomized Double-blinded, Double Dummy, Active-controlled, Parallel Design, Phase 3 Clinical Trial to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia, Not Adequately Controlled on Statin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 305
- 试验地点
- 40
- 主要终点
- Percent change in measured LDL-C from baseline (the last available measured LDL-C value obtained up to randomization) to Week 8
研究概览
简要总结
Primary Objective:
To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol (LDL-C) after 8 weeks.
Secondary Objectives:
- To evaluate the proportion of patients who attain their LDL-C goal.
- To evaluate the effect of SPC (E10/R10) compared to rosuvastatin 10 mg (R10) in reduction of LDL-C at Week 4.
- To evaluate the effect of SPC (E10/R10) compared to R10 on other lipid parameters at Week 4 and Week 8.
- To evaluate the safety of SPC (E10/R10) and R10.
详细描述
Study duration per participants is approximatively 16 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rosuvastatin
Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks
干预措施: Rosuvastatin active capsule (Drug)
Single pill combination (SPC)
Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks
干预措施: Rosuvastatin (Drug)
Single pill combination (SPC)
Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks
干预措施: SPC ezetimibe/rosuvastatin (Drug)
Single pill combination (SPC)
Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks
干预措施: Placebo (Drug)
Rosuvastatin
Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks
干预措施: Rosuvastatin (Drug)
Rosuvastatin
Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in measured LDL-C from baseline (the last available measured LDL-C value obtained up to randomization) to Week 8
时间窗: Baseline to Week 8
The percent change from baseline in measured LDL-C at Week 8 will be analyzed in the modified intent-to-treat (mITT) population using a mixed effect model with repeated measures (MMRM) approach.
次要结局
- Proportion of patients who attain lipid goal (measured LDL-C <2.6 mmol/L [100 mg/dL]) at Week 8(Week 8)
- Percent change in measured LDL-C plasma level from baseline to Week 4(Baseline to Week 4)
- Percent change in total cholesterol (TC) from baseline to Week 8(Baseline to Week 8)
- Percent change in TG serum levels from baseline to Week 4(Baseline to Week 4)
- Percent change in high density lipoprotein cholesterol (HDL-C) from baseline to Week 8(Baseline to Week 8)
- Percent change in TC from baseline to Week 4(Baseline to Week 4)
- Percent change in triglyceride (TG) serum levels from baseline to Week 8(Baseline to Week 8)
- Percent change in HDL-C from baseline to Week 4(Baseline to Week 4)
- Number of patients with adverse events (AEs)(Up to 16 weeks (±3 days))