NCT00320060已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes
BioStratum0 个研究点目标入组 128 人开始时间: 2001年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
- •Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1
- •Hemoglobin A1C <=12% at week -2
- •Patients with diagnosis of diabetic nephropathy as defined by
- •Serum Creatinine <=2.0 mg/dL at weeks -2 and -1
- •Urinary albumin excretion >=300 mg/24 hours at week -2
- •Diagnosis of diabetic retinopathy
- •Creatinine clearance >=40 mL/min at weeks -2 and -1
- •Voluntary written consent to participate in this study
排除标准
- •History of allergic or adverse response to any B vitamin
- •History of major cardiovascular or cerebrovascular events
- •History of cancer except adequately treated basal or squamous cell carcinoma of the skin
- •History of diabetic ketoacidosis
研究者
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