EUCTR2005-003158-91-PT进行中（未招募）不适用
THE COLLABORATIVE STUDY GROUP TRIAL: THE EFFECT OF SULODEXIDE IN PATIENTS WITH TYPE 2 DIABETES AND MICROALBUMINURIA - Sulodexide in Type 2 Diabetes with Microalbuminuria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The principle inclusion criteria for the study includes men and women with type 2 diabetes and persistent microalbuminuria (in men urine albumin creatinine ratio [ACR] 35 – 200 mg albumin/G creatinine [4.0 - 22.6 mg/mmol], in women urine ACR 45 – 200 mg albumin/G creatinine [5.1 – 22.6 mg/mmol] based on the geometric mean of 3 first voided AM urine samples at the qualifying visit [Visit 6]). Patient’s serum creatinine must be less than or equal to 1.5 mg/dL at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Age of onset of type 2 diabetes <18 years;
- •2.HbA1C >10.0%;
- •3.Morbid obesity defined as a body mass index (BMI) more than or equal to 45 kg/m2;
- •4.Type 1 (insulin-dependent; juvenile onset) diabetes;
- •5.Renal disease as follows:
- •Patients with known non-diabetic renal disease (nephrosclerosis superimposed on diabetic nephropathy acceptable);
- •Renal allograft;
- •6.Absolute requirement for combination therapy of ACEI and ARB;
- •7.Known allergies or intolerance to any heparin-like compound;
- •8.Untreated urinary tract infection that would impact urinary protein values; or
- •9.Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
研究者
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