NCT05809687撤回3 期
Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A 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
- 撤回
- 入组人数
- 512
- 主要终点
- Percent change (%) of non-HDL-C from baseline
研究概览
简要总结
Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A
详细描述
Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102_A alone.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A man or woman over 19 years old.
- •Patients with coronary heart disease or risk of coronary heart disease
排除标准
- •History of Unstable angina, myocardial infarction etc
- •Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%)
- •renal impairment (Creatinine clearance < 60 mL/min) etc.
研究组 & 干预措施
Control group
Active Comparator
DKP21102_A, DKP21102_C
干预措施: DKP21102_C (Drug)
Control group
Active Comparator
DKP21102_A, DKP21102_C
干预措施: DKP21102_A (Drug)
Treatment group
Experimental
DKP21102_A, DKP21102_B
干预措施: DKP21102_B (Drug)
Treatment group
Experimental
DKP21102_A, DKP21102_B
干预措施: DKP21102_A (Drug)
结局指标
主要结局
Percent change (%) of non-HDL-C from baseline
时间窗: from baseline at 12weeks
non-HDL-C
次要结局
未报告次要终点
研究者
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