NCT03156842已完成3 期
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia Who Fail to Respond Adequately to Fimasartan Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Sitting systolic blood pressure(SiSBP)
研究概览
简要总结
The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provided a written consent to participate in this clinical study
- •Male or female adults aged 19-70 years
- •Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
- •Uncontrolled blood pressure (140 mmHg ≤ mean Sitting systolic blood pressure(SiSBP) < 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy
- •Subjects who meet the following criteria of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC)
- •Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3)
- •Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
排除标准
- •Severe hypertension with mean Sitting systolic blood pressure(SiSBP) ≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the baseline visit (V2, or orthostatic hypotension accompanied by symptoms
- •Differences between arms greater than 20 mmHg for Sitting systolic blood pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on 3 consecutive readings at the screening visit (V1)
- •Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
- •Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit of normal at the pre-baseline visit (V2))
- •Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1)
- •Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
- •Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
- •Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
- •Pregnant or lactating women
- •Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods (Contraceptive methods: Refer to Section 10.1 in this document.)
研究组 & 干预措施
Fimasartan/Amlodipine, Rosuvastatin
Experimental
Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin
干预措施: Fimasartan/Amlodipine, Rosuvastatin (Drug)
Fimasartan/Amlodipine
Active Comparator
a fixed dose combination of Fimasartan/Amlodipine
干预措施: Fimasartan/Amlodipine (Drug)
Fimasartan, Rosuvastatin
Active Comparator
Co-administration of Fimasartan and Rosuvastatin
干预措施: Fimasartan, Rosuvastatin (Drug)
结局指标
主要结局
Sitting systolic blood pressure(SiSBP)
时间窗: 8weeks from Baseline Visit
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
LDL-C
时间窗: 8weeks from Baseline Visit
The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group
次要结局
- Sitting systolic blood pressure(SiSBP)(8weeks from Baseline Visit)
- LDL-C(8weeks from Baseline Visit)
研究者
研究点 (1)
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