drugset / Trial / NCT00320879

Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria

NCT00320879

Phase 4 Completed 52 enrolled Steno Diabetes Center Copenhagen
RandomizedCrossoverDouble-blindTreatment

Summary

Aim: To evaluate the renoprotective effect as reflected by short-term changes in albuminuria of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design: A double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients with microalbuminuria on ongoing antihypertensive medication. At inclusion, previous antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg o.d. for the entire study. Following two months wash-out (baseline), patients will be treated randomly with irbesartan 300, 600 and 900 mg o.d., each dose for two months. End-points evaluated at the end of each study period include urinary albumin excretion rate (UAE, mean of three 24-hrs collections), 24-hrs blood pressure (ABP); and GFR (51Cr-EDTA).

Timeline

Start
2003-09
Primary completion
Completion
2004-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Irbesartan Small molecule 300 mg
Subject Irbesartan Small molecule 600 mg
Subject Irbesartan Small molecule 900 mg