A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-828, D326, and D337 Combination Therapy in Hypertensive Patients With Dyslipidemia
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change rate from baseline in Low Density Lipoprotein-C
研究概览
简要总结
to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia
详细描述
The purpose of this phase III study was to evaluate the efficacy and safety of CKD-348(CKD-828, D326, D337) tablet administration for treatment period(8 weeks) in essential hypertesive 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 19 years and 75 years old(male or female)
- •Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs
- •The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion
- •Agreement with written informed consent
排除标准
- •Patients whose blood pressure measured at screening is one of the following:
- •Mean Sitting Systolic Blood Pressure ≥ 200 mmHg or Mean Sitting Diastolic Blood Pressure ≥ 120 mmHg
- •Difference in Mean Sitting Systolic Blood Pressure between patient's both arms ≥ 20 mmHg and Mean Sitting Diastolic Blood Pressure ≥ 10 mmHg
- •Patients whose lipid level measured at screening is one of the following:
- •Low Density Lipoprotein-C > 250 mg/dL or Triglyceride ≥ 500 mg/dL
- •Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
研究组 & 干预措施
Treatment group
Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: CKD-828 (Drug)
Treatment group
Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D326 (Drug)
Treatment group
Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D337 (Drug)
Treatment group
Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D013(placebo) (Drug)
Comparator group 1
Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: CKD-828 (Drug)
Comparator group 1
Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D326(placebo) (Drug)
Comparator group 1
Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D337(placebo) (Drug)
Comparator group 1
Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D013(placebo) (Drug)
Comparator group 2
Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg
- CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: CKD-828(placebo) (Drug)
Comparator group 2
Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg
- CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D326 (Drug)
Comparator group 2
Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg
- CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D337 (Drug)
Comparator group 2
Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg
- CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks
干预措施: D013 (Drug)
结局指标
主要结局
Change rate from baseline in Low Density Lipoprotein-C
时间窗: Baseline, 8 weeks
(compare treatment group with comparator group 1)
Change from baseline in Mean Sitting Systolic Blood Pressure
时间窗: Baseline, 8 weeks
(compare treatment group with comparator group 2)
次要结局
- Change rate from baseline in Low Density Lipoprotein-C(Baseline, 4 weeks)
- Low Density Lipoprotein-C target achievement rate accroding to National Cholesterol Education Program(NCEP) Third Adult Treatment Panel(ATP III) guideline at 4 weeks and 8 weeks(Baseline, 4 weeks, 8 weeks)
- Change from baseline in Low Density Lipoprotein-C(Baseline, 4 weeks, 8 weeks)
- Change from baseline in Mean Sitting Systolic Blood Pressure(Baseline, 4 weeks)
- Change from baseline in Mean Sitting Diastolic Blood Pressure(Baseline, 4 weeks, 8 weeks)
- Normalization rate of blood pressure after 4 weeks and 8 weeks(Baseline, 4 weeks, 8 weeks)
- Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C(Baseline, 4 weeks, 8 weeks)