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 the incidence of microalbuminuria more effectively than Benazepril or Valsartan alone in hypertensive patients with type 2 diabetes and high-normal albuminuria VARIETY Study - VARIETY Study

Phase 1

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

• Registration Number: EUCTR2006-005954-62-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
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1233

Inclusion Criteria

-Males and females 40 years old; -High-risk subjects with type 2 diabetes WHO criteria ; -History of diabetes not exceeding 25 years; -High blood pressure systolic and/or diastolic blood pressure 135/85 mmHg or concomitant treatment with blood pressure lowering medications ; -Serum creatinine concentration 1.5 mg/dl; -Overnight urinary albumin excretion in at least 2 of 3 consecutive overnight urine collections 10 and 20 g/min; -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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Uncontrolled diabetes glycated hemoglobin 11 ; -Specific contraindications or history of hypersensitivity to the study drugs; -Serum potassium 8805; 5.5 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