A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients With Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 16
- 主要终点
- Change rate from baseline in LDL-C
研究概览
简要总结
To Evaluate the Efficacy and Safety of CKD-333
详细描述
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia
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
- Double (Participant, Investigator)
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
- •Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period
- •Lipid levels measured after run-in period were:
- •Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
- •Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL
- •Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL
排除标准
- •Patients whose blood pressures measured at Visit 2 were:
- •Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg
- •Patients who had lipid levels measured at Visit 2
- •Patients with fasting LDL-C <100 mg / dL or fasting LDL-C> 250 mg / dL and / or TG ≥ 500 mg / dL
研究组 & 干预措施
Experimental Group 1
Patients assigned to this group are treated with CKD-330, D086
干预措施: D086 (Drug)
Experimental Group 1
Patients assigned to this group are treated with CKD-330, D086
干预措施: CKD-330 (Drug)
Experimental Group 1
Patients assigned to this group are treated with CKD-330, D086
干预措施: Placebo of D723 (Drug)
Placebo Group 1
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)
干预措施: CKD-330 (Drug)
Placebo Group 1
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)
干预措施: Placebo of D086 (Drug)
Placebo Group 1
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)
干预措施: Placebo of D723 (Drug)
Placebo Group 2
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)
干预措施: Placebo of CKD-330 (Drug)
Placebo Group 2
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)
干预措施: D086 (Drug)
Placebo Group 2
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)
干预措施: D723 (Drug)
结局指标
主要结局
Change rate from baseline in LDL-C
时间窗: 8 weeks after drug administrations
Compare experimental group 1 with placebo group 1
Change from baseline in MSSBP
时间窗: 8 weeks after drug administrations
Compare experimental group 1 with placebo group 2
次要结局
- Change from baseline in LDL-C(4, 8 weeks after drug administrations)
- change rate from baseline in TC(4, 8 weeks after drug administrations)
- Change from baseline in TG(4, 8 weeks after drug administrations)
- Change from baseline in HDL-C(4, 8 weeks after drug administrations)
- Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline(4, 8 weeks after drug administrations)
- Change from baseline in TC(4, 8 weeks after drug administrations)
- change rate from baseline in HDL-C(4, 8 weeks after drug administrations)
- Change rate from baseline in LDL-C(4 weeks after drug administrations)
- Change from baseline in MSSBP(mmHg)(4 weeks after drug administrations)
- Change from baseline in MSDBP(4, 8 weeks after drug administrations)
- Attainment of normal blood pressure as defined by JNC Ⅶ(4, 8 weeks after drug administrations)
- change rate from baseline in TG(4, 8 weeks after drug administrations)