NCT00095290已完成4 期
Irbesartan Versus Placebo in Combination With Standard Cardiovascular Protection ACE-I Therapy With Ramipril for the Treatment of Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in AER from baseline to Week 20
研究概览
简要总结
Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing and able to provide written informed consent.
- •Males and Females 55 years of age and over
- •Subjects must have a history of high blood pressure and elevated cardiovascular risk defined as one of the following:
- •Advanced coronary disease defined as previous myocardial infarction. Active angina, or significant changes in tests indicating ischemia
- •Artery disease in the legs, limiting walking capacity and/or blood flow in the legs
- •Stroke occurring more than 3 months prior to the screening visit
- •All subjects must also have albuminuria (protein in the urine) that is confirmed by a urine test at the first study visit.
- •All subjects must currently be treated with a class of drugs called ACE inhibitors (e.g., benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) for at least 2 months prior to the study.
- •Women of childbearing potential (WOCBP) must be using adequate methods of contraception to avoid pregnancy throughout the study and four weeks after the study ends.
排除标准
- •Women who are pregnant or breastfeeding.
- •Acute systemic febrile/infectious disease or infectious or inflammatory disease of the kidneys
- •Narrowing of the kidney arteries
- •Hypotension (low blood pressure) or very high blood pressure
- •Moderate or Severe Heart Failure
- •Chronic autoimmune disease
- •Cancer unless cured or no further treatment needed
- •Severe kidney failure
- •Allergy to drugs used in the study: ARBs (candesartan, irbesartan, losartan, telmisartan, valsartan, and/or any other ARB currently or previously in development) and ACE-inhibitors (benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril)
- •Administration of any other investigational drug within 30 days of planned enrollment into the study.
- •Any circumstances that would prevent coming for study visits or taking study drugs
研究组 & 干预措施
A1
Experimental
干预措施: Ramipril + Irbesartan (Drug)
A2
Placebo Comparator
干预措施: Ramipril + Placebo (Drug)
结局指标
主要结局
Change in AER from baseline to Week 20
次要结局
- Change from baseline in seated systolic and diastolic blood pressures at Week 20; Comparison of change from baseline in seated systolic and diastolic blood pressures at Week 20 between treatment groups
研究者
研究点 (1)
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