NCT03639480Unknown3 期
A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of CJ-30061 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Atorvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in LDL-C
研究概览
简要总结
To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 74 years
- •Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
- •Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study
排除标准
- •Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
- •The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
- •LDL-C > 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
- •Secondary hypertension
- •Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)
研究组 & 干预措施
Test
Experimental
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
干预措施: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg (Drug)
Reference 1
Active Comparator
Amlodipine 10mg+Valsartan 160mg
干预措施: Amlodipine 10mg+Valsartan 160mg (Drug)
Reference 2
Active Comparator
Valsartan 160mg+Atorvastatin 40mg
干预措施: Valsartan 160mg+Atorvastatin 40mg (Drug)
结局指标
主要结局
Change in LDL-C
时间窗: baseline and 8 weeks
Change in LDL-C from baseline after 8 weeks of study treatment
Change in siSBP
时间窗: baseline and 8 weeks
Change in siSBP from baseline after 8 weeks of study treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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