Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

Phase 4 Completed 400 enrolled Bristol-Myers Squibb Sanofi · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.

Timeline

Start: 2004-09
Primary completion: 2005-11
Completion: 2005-11

Outcome

Missed primary endpoint

paper Adjusted week 20 baseline geometric ratios for ramipril plus irbesartan and ramipril plus placebo were not significantly different. PMID 17667984 ↗

Publications

Bakris GL, Ruilope L, Locatelli F, Ptaszynska A, Pieske B, de Champlain J, Weber MA, Raz I. Treatment of microalbuminuria in hypertensive subjects with elevated cardiovascular risk: results of the IMPROVE trial. Kidney Int. 2007 Oct;72(7):879-85. doi: 10.1038/sj.ki.5002455. Epub 2007 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irbesartan	Small molecule	300 mg	Oral
Comparator	Ramipril	Small molecule	10 mg	Oral