Trial | NCT03073018  Report issue

Official Title

Prevention of Renal and Vascular Endstage Disease Intervention Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fosinopril pravastatin ...

  • Study Participants

    864
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.
This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/ day will prevent cardiovascular and renal disease in nonhypertensive (RR <160/100 mm Hg and not using antihypertensive medication) and nonhypercholesterolemic (total cholesterol <8.0 or <5.0 mmol/L in case of previous myocardial infarction and not using lipid lowering medication) men and women with persistent microalbuminuria (urinary albumin excretion >10 mg/L once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). The Prevention of REnal and Vascular ENdstage Disease Intervention Trial is a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design. The 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. The primary efficacy parameter is defined as the combined incidence of all-cause mortality or hospital admission for documented (1) nonfatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease.
Study Started
Apr 30
1998
Primary Completion
Jun 30
2003
Study Completion
Nov 30
2003
Last Update
Mar 10
2017

Drug Fosinopril

oral administration, capsules

  • Other names: Monopril

Drug Pravastatin

oral administration, capsules

  • Other names: Pravachol

Drug Fosinopril Placebo

oral administration, capsules

Drug Pravastatin Placebo

oral administration, capsules

Fosinopril + Pravastatin Experimental

Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years

Fosinopril + Placebo Active Comparator

Fosinopril (20 mg) + pravastatin placebo once daily for 4 years

Pravastatin + Placebo Active Comparator

Pravastatin (40 mg) + fosinopril placebo once daily for 4 years

Double Placebo Placebo Comparator

Fosinopril placebo and pravastatin placebo once daily for 4 years

Criteria 

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
No Results Posted