The effects of the association bindarit irbesartan versus irbesartan alone on albuminuria of patients with Diabetic Nephropathy. Placebo-controlled study. - ND

• Conditions: Patients with type II diabetes with nephropathy; MedDRA version: 9.1Level: SOCClassification code 10047065Term: Vascular disorders

• Registration Number: EUCTR2006-006191-38-IT
• Lead Sponsor: ANGELINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients may be enrolled under the following circumstances males and females 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 g/min in at least 2 of 3 overnight urine samples or macroalbuminuria defined as urinary albumin excretion, 200 g/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 Brenner 2000 ; serum creatinine 8804; 3 mg/dL; 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; 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

Exclusion Criteria

Patients cannot enter the trial under the following circumstances patients hypersensitive or allergic to ARBs, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified