A prospective, randomized, open label blinded end point probe trial to evaluate whether, at comparable blood pressure control, combined therapy with the ACE inhibitor Benazepril and the angiotensin II receptor blocker ARB Valsartan reduces progression to ESRD more effectively than Benazepril or Valsartan alone in high risk patients with type 2 diabetes and overt nephropathy VALID Study - VALID Study

Phase 1

• Conditions: Diabetic nephropathy; MedDRA version: 6.1Level: PTClassification code 10061835

• Registration Number: EUCTR2006-005951-14-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-29
• Study Completion: 2016-04-15
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

-Males and females 40 years old; -High-risk subjects with type 2 diabetes WHO criteria ; -Serum creatinine concentration of 1.8 mg/dl or more but les than 3.5 mg/dl ; -Urinary albumin to creatinine ratio of 2000mg/g or more in spot morning urine ; -Written informed consent.
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

-Specific contraindications or history of hypersensitivity to the study drugs or other; -Serum potassium 8805; 6 mEq/L despite diuretic therapy, and optimized metabolic and acid/base control; -Bilateral renal artery stenosis; -Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer; -Drug or alcohol abuse; -Any chronic clinical conditions that may affect completion of the trial or confound data interpretation; -Pregnancy or lactating; -Women of childbearing potential without following a scientifically accepted form of contraception; -Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial; -Evidence of an uncooperative attitude; -Any evidence that patient will not be able to complete the trial follow-up.

Study & Design

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