NCT07685054尚未招募不适用
A Multicenter, Prospective Observational Study to Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe' in Patients With Essential Hypertension and Primary Hypercholesterolemia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12,700
- 主要终点
- The proportion of patients with positive urine dipstick albuminuria
研究概览
简要总结
This prospective study aims to observe changes in renal function and related parameters in patients with essential hypertension and primary hypercholesterolemia receiving either the combination of fimasartan and atorvastatin or the combination of fimasartan, atorvastatin, and ezetimibe.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information.
- •Patients diagnosed with essential hypertension and primary hypercholesterolemia.
- •Patients scheduled to receive either fimasartan plus atorvastatin or fimasartan plus atorvastatin plus ezetimibe.
排除标准
- •Patients who received concomitant administration of fimasartan and atorvastatin within 4 weeks prior to baseline.
- •Patients with any contraindication to fimasartan, atorvastatin, or ezetimibe as specified in the approved product labeling.
- •Patients who have received investigational or study drugs from another clinical trial or research study within 12 weeks prior to baseline. However, participation in non-interventional observational studies is permitted.
- •Patients considered unsuitable for study participation at the discretion of the principal investigator or sub-investigator.
结局指标
主要结局
The proportion of patients with positive urine dipstick albuminuria
时间窗: Week 12
次要结局
- Change in UACR from baseline to Weeks 12 and 24(Week 12, Week 24)
- Proportion of participants achieving a ≥30% reduction in UACR from baseline at Weeks 12 and 24(Week 12, Week 24)
- Change in UPCR from baseline to Weeks 12 and 24(Week 12, Week 24)
- Proportion of participants achieving a ≥30% reduction in UPCR from baseline at Weeks 12 and 24(Week 12, Week 24)
- Change in eGFR from baseline to Weeks 12 and 24(Week 12, Week 24)
- Proportion of participants with a ≥50% decline in eGFR from baseline at Weeks 12 and 24(Week 12, Week 24)
- Change in blood pressure from baseline at Weeks 12 and 24(Week 12, Week 24)
- Proportion of participants achieving the target blood pressure at Weeks 12 and 24(Week 12, Week 24)
- Change in lipid profile (TC, HDL-C, TG, and LDL-C) from baseline at Weeks 12 and 24(Week 12, Week 24)
- Proportion of participants achieving the target LDL-C level at Weeks 12 and 24(Week 12, Week 24)
- Proportion of participants achieving both the target blood pressure and target LDL-C level at Weeks 12 and 24(Week 12, Week 24)
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