NCT06431477招募中4 期
A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)
研究概览
简要总结
A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension
详细描述
A Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared with Losartan in Patients with Diabetic Nephropathy and Hypertension
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
- None
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
- •Male of Female subjects aged ≥19 or <75
- •Type II Diabetes Mellitus subjects who have been taken medicine
- •Subjects who have voluntarily decided to participate in this clinical trial and Signed ICF
排除标准
- •Subjects with Type I Diabetes Mellitus
- •Subjects with Primary hyper-aldosteronism
- •Subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening
- •Pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period
- •Subjects who received other clinical trial drugs within 28 days of screening visit
- •Subjects who are unable to participate in this clinical trial at the discretion of the investigator.
研究组 & 干预措施
Losartan tablet
Active Comparator
干预措施: Losartan (Drug)
Telmisartan tablet
Experimental
干预措施: telmisartan (Drug)
结局指标
主要结局
Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)
时间窗: 24 weeks after drug administration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Telmisartan and Losartan in Primary HypertensionHypertensionNCT02269176Boehringer Ingelheim330
已完成
4 期
Telmisartan in Mild to Moderate Hypertensive PatientsHypertensionNCT02260089Boehringer Ingelheim134
已完成
3 期
Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/RosuvastatinDyslipidemia With HypertensionNCT03088254Jeil Pharmaceutical Co., Ltd.126
已完成
1 期
Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult VolunteersHypertension With HyperlipidemiaNCT03461081Jeil Pharmaceutical Co., Ltd.32
已完成
4 期
Telmisartan With or Without Hydrochlorothiazide (HCTZ) Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive PatientsHypertensionNCT02172586Boehringer Ingelheim363