NCT04074551已完成3 期
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2019年7月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Change from baseline in LDL-C (%)
研究概览
简要总结
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and 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 who understood the contents and purpose of this trial and signed informed consent form
- •Patients with essential hypertension and dyslipidemia
排除标准
- •Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- •Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
- •Concomitant administration of cyclosporine
- •Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
- •Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers
- •Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
- •CPK normal range > 2 times
- •Secondary hypertension and suspected secondary hypertension
- •Orthostatic hypotension with symptoms
- •Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
- •Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
- •Active gout or hyperuricemia(uric acid ≥ 9mg/dL)
- •IDDM or uncontrolled type 2 diabetes mellitus (HbA1c > 9%)
- •Ventricular arrhythmia
- •Medical history
- •Severe heart disease(heart failure of NYHA class III-IV)
- •Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA)
- •Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve
- •Ischemic heart disease(myocardial infarction, angina) within 6months
- •Angioplasty or coronary artery bypass graft(CABG) surgery within 6months
研究组 & 干预措施
Experimental
Experimental
HCP1701
干预措施: HCP1701 (Drug)
Active Comparator 1
Active Comparator
HGP0904, HGP0608
干预措施: Losartan (Drug)
Active Comparator 1
Active Comparator
HGP0904, HGP0608
干预措施: Amlodipine (Drug)
Active Comparator 2
Active Comparator
HGP0608, HCP1306
干预措施: Losartan (Drug)
Active Comparator 2
Active Comparator
HGP0608, HCP1306
干预措施: Rosuvastatin and Ezetimibe (Drug)
结局指标
主要结局
Change from baseline in LDL-C (%)
时间窗: baseline, 8 weeks
Experimental, Active Control 1
Change from baseline in sitting systolic blood pressure
时间窗: baseline, 8 weeks
Experimental, Active Control 2
次要结局
- Change from baseline in sitting distolic blood pressure(baseline, 4 weeks, 8 weeks)
- Proportion of subject achieving LDL-C control(baseline, 4 weeks, 8 weeks)
- Proportion of subjects achieving blood pressure control(baseline, 4 weeks, 8 weeks)
- Proportion of responder for blood pressure(baseline, 4 weeks, 8 weeks)
- Change from baseline in TC, HDL-C, TG (%)(baseline, 4 weeks, 8 weeks)
- Proportion of subject achieving both LDL-C and blood pressure control(baseline, 4 weeks, 8 weeks)
- Change from baseline in sitting systolic blood pressure(baseline, 4 weeks)
- Change from baseline in LDL-C (%)(baseline, 4 weeks)
研究者
研究点 (1)
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