Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria
Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 4
Details
Lead Sponsor:
Steno Diabetes Center Steno Diabetes Center Copenhagen