NCT00550095已完成4 期
A 24 Week, Multi-centre, Open Label, Non Controlled Study to Assess the Efficacy of Valsartan in Reducing Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus
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
- Novartis
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.
研究概览
简要总结
This study is designed to assess the efficacy of the different dosage forms of Valsartan[80, 160, and 320 mg] in reducing microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 35 to
- •Type 2 diabetes mellitus (DM) patients coupled with hypertension [sitting systolic blood pressure (SSBP) 140-179 mm Hg and/or SDBP 90-109 mm Hg].
- •Urinary albumin creatinine Ratio (UACR)) indicating microalbuminuria/proteinuria [30-1000 mg/g or 2.5-25 mg/mmol]
- •Body mass index (BMI) <40 kg/m2
- •Patients who will sign an informed consent.
- •Exclusion Criteria
- •Type 1 DM
- •All causes of secondary diabetes mellitus
- •Women of childbearing potential who refuse to use contraception.
- •Pregnant or lactating females.
- •Severe hypertension [SSBP> 180 mmHg, sitting diastolic blood pressure (SDBP) > 110 mmHg ]
- •Patients who are on combo therapy to control BP
- •Patients who are already on Valsartan.
- •Hypersensitivity to Valsartan.
- •Renal artery stenosis [ unilateral or bilateral]
- •Patients taking β blockers, (Angiotensin Converting Enzyme Inhibitor (ACEI) or spironolactone
- •Heart Failure
- •History of myocardial infarction, Percutaneous Transluminal Coronary Angioplasty(PTCA) or cerebrovascular accident within the preceding 3 months.
- •Creatinine levels > 1.4 mg/dl [ 0.07mmol/l]. Liver enzymes > 2 times Upper Limit of the Normal Range(ULN). Diabetic keto-acidosis (DKA) within the last 6 months. Presence of diabetic neuropathy or retinopathy. Diabetic foot complications. Presence of infection at time of screening. Hyperkalemia (serum K+ > 5.5 mmol/L)
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
valsartan
干预措施: valsartan (Drug)
结局指标
主要结局
Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.
时间窗: Week 24
次要结局
- Percent reduction of (BP) at 24 weeks compared to baseline level. Percent of patients whose BP is controlled at 24 weeks (< 130/80)(Week 24)
研究者
研究点 (1)
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