The effects of the association bindarit + irbesartan versus irbesartan alone on albuminuria of patients with Diabetic Nephropathy. Double-blind placebo-controlled study followed by an open extension phase.

Angelini Farmaceutici, ACRAF S.p.A.0 个研究点目标入组 50 人开始时间: 2008年3月4日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•male and female patients with no limitation of race, aged 30 to 70 years; • Type 2 diabetes defined as: > 30 years of age at diagnosis; insulin not required within 6 months of initial diagnosis; no history of diabetic ketoacidosis; currently treated with diet, oral hypoglycemics or insulin [Brenner 2000]; • microalbuminuria defined as urinary albumin excretion, 20 to 200 µg/min in at least 2 of 3 overnight urine samples or macroalbuminuria defined as urinary albumin excretion, > 200 µg/min in at least 2 of 3 overnight urine samples, confirmed in the baseline collection; should baseline albuminuria data not to be available, the patient may be conditionally treated; • glycosylated haemoglobin (Hb A1c) <12% at Screening [Brenner 2000]; • serum creatinine = 3 mg/dL at Screening; • normotensive patients or hypertensive patients on stable antihypertensive therapy over the last 3 months and without specific contraindications to angiotensin antagonist therapy; • female patients of childbearing potential required to have a negative pregnancy test and use an approved birth control method; • patients legally able to give written informed consent to the trial (signed and dated by the patient).
•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

•patients hypersensitive or allergic to ARBs or bindarit or its components, or with a positive history for drug allergy; • Type 1 diabetes [Brenner 2000]; • history of non diabetic renal disease, including renal artery stenosis [Brenner 2000]; • history of heart failure before enrolment [Brenner 2000]; • acute myocardial infarction, coronary artery bypass grafting within the past one month [Brenner 2000]; • cerebral vascular accident or coronary angioplasty within the past six months month [Brenner 2000]; • Transient Ischemic Attacks (TIA) in the past 12 months [Brenner 2000]; • primary aldosteronism or pheocromocytoma [Brenner 2000]; • severe uncontrolled hypertension (sitting diastolic blood pressure > 115 and/or sitting systolic blood pressure> 220 mm Hg) in the previous 6 months; • chronic use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressive drugs, MAO inhibitors; • patients under the influence of alcohol or narcotics; • patients treated with experimental drugs in the previous 4 weeks.

发起方

Angelini Farmaceutici, ACRAF S.p.A.