NCT00308347已完成3 期
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes Mellitus and Nephropathy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,513
- 主要终点
- Combined endpoint of doubling of serum creatinine, ESRD or death.
研究概览
简要总结
Evaluate the effect of Losartan in reducing kidney disease in patients with Non-insulin Dependent Diabetes and Nephropathy (kidney damage that usually accompanies late stage Diabetes Mellitus).
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
- 31 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes diagnosed after the age of 30
- •Insulin not required within 6 months of first being diagnosed with Non-insulin Dependent Diabetes Mellitus
- •No history of diabetic ketoacidosis
- •Patients may be currently treated with diet, oral hypoglycemics or insulin
- •Patients must have proteinuria defined as: Urine protein >1+ on dipstick at the initial screening visit
- •Patients with hypertension (high blood pressure) must have a sitting blood pressure >200/110 mm Hg at Visit 1
排除标准
- •Patients with insulin-dependent diabetes mellitus (juvenile onset)
- •Patients treated with an ACE inhibitor or angiotensin II antagonist (AIIA) for >5 years
- •Patients treated with ACE inhibitor or AIIA therapy for 5 years or less may enter the study provided therapy is discontinued during the 6 week screening period prior to randomization
- •History of myocardial infarction (MI) (heart attack) or coronary artery bypass graft (CABG) surgery within the past 1 month
- •History of cerebral vascular accident (CVA) (stroke) or percutaneous transluminal coronary angioplasty (PTCA) within the past 6 months
- •History of transient ischemic attacks (TIA) within the past year. Patients with unstable angina are excluded until stabilized
- •Heart failure requiring ACE inhibitor therapy
- •Steroids (oral or parenteral) or immunosuppressives are not permitted. Debilitating psychological illness
- •Evidence of significant hepatic (liver) dysfunction: History of allergy to losartan
- •Known positive test for HIV or patients known to be hepatitis B or C antigen carriers
- •Pregnant or nursing women
- •Females of childbearing age must either be surgically sterilized or, if sexually active, using an effective form of contraception and may enter only if an exclusionary pregnancy test is done within approximately 72 hours prior to randomization
- •Pregnancy tests will be done every 3 months during the study and at the time of discontinuation
结局指标
主要结局
Combined endpoint of doubling of serum creatinine, ESRD or death.
次要结局
- Secondary parameters: number of cardiovascular events and changes in proteinuria. Tertiary parameters: quality of life and healthcare resource utilization.
研究者
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