CompletedPhase 3

Prevention of Renal and Vascular Endstage Disease Intervention Trial

864 participantsStarted 1998-04

Plain-language summary

The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Persistent microalbuminuria (urinary albumin excretion \>10mg/L once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples) * No hypertension (RR \<160/100 mm Hg, no anti-hypertensive medication) * No hypercholesterolemia (total cholesterol \<8.0 or \<5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication) Exclusion Criteria: * Creatinine clearance \>60% of the normal age-adjusted value * Serum potassium \>5.5 mmol/L * History of chronic liver disease * Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase \>3 times the upper limit of normal * Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists * Use of insulin * Previously documented allergy or intolerance to study drugs * Pregnant or nursing women

What they're measuring

Combined incidence of all-cause mortality, MACE and/or end-stage renal disease

Timeframe: 4 years

Trial details

NCT IDNCT03073018

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2003-06

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