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临床试验/NCT01230034
NCT01230034Unknown3 期

Randomized, Controlled, PROBE Trial, Evaluating the Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic Patients and Mild to Moderate Hypertension With Microalbuminuria

University of Pavia1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
206
试验地点
1
主要终点
Size of the reduction of urinary albumin in 24 hours to the various controls

研究概览

简要总结

Numerous clinical and experimental data show that the elective treatment of diabetic nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS). Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists II have proven effective in reducing proteinuria in power even if different therapeutic drug to drug. ACE inhibitors are one of the most known and used treatment options for blocking the renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril, lisinopril and ramipril are standard therapy in diabetic patients with micro or macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of view, the same or varies from drug to drug. This is particularly true in the diabetic microalbuminuria, a condition in which there is sufficient documentation to prove that ramipril is effective. The main objective of this study was to assess the magnitude and trend of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die imidapril versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and microalbuminuria.

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
None

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

入选标准

  • Blood pressure> 130/80 ≤ 170/100 mmHg at the end of the period of wash-out
  • Type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
  • Microalbuminuria in the upper range of normal (> 150 <300 mg/24 h)

排除标准

  • Pregnancy, lactation or women of childbearing age.
  • Inability to stop treatment in place for a few days during the wash-out.
  • Sitting diastolic blood pressure> 100 mmHg or systolic pressure> 170 at the end of the wash-out.
  • History of hypertensive encephalopathy or cerebrovascular accident within 12 months prior.
  • Secondary hypertension.
  • Heart failure
  • Acute myocardial infarction; angina pectoris
  • Liver and kidney dysfunction
  • Known hypersensitivity to ACE inhibitors
  • All other physiological or pathological condition that the physician may affect the evaluation of the parameters under study or interfere with the proper conduct of the study.

研究组 & 干预措施

Imidapril

Experimental

10 and 20 mg/day, pill

干预措施: Imidapril (Drug)

Ramipril

Active Comparator

5 and 10 mg/day, pill

干预措施: Ramipril (Drug)

结局指标

主要结局

Size of the reduction of urinary albumin in 24 hours to the various controls

时间窗: After 12 weeks from the beginning

次要结局

  • 1. Size of the reduction of mean 24-hour average daytime and nighttime average. 2. Size of the reduction of central blood pressure. 3. Magnitude of changes in plasma concentrations of angiotensin II, bradykinin and BNP after 24 weeks of treatment.(After 12 weeks from the beginning)

研究者

申办方类型
Other

研究点 (1)

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