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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00320879
Other study ID # 26122284
Secondary ID
Status Completed
Phase Phase 4
First received May 1, 2006
Last updated May 17, 2006
Start date September 2003
Est. completion date November 2004

Study information

Verified date July 2003
Source Steno Diabetes Center
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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).


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
irbesartan


Locations

Country Name City State
Denmark Steno Diabetes Center Gentofte Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Steno Diabetes Center

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Rossing K, Schjoedt KJ, Jensen BR, Boomsma F, Parving HH. Enhanced renoprotective effects of ultrahigh doses of irbesartan in patients with type 2 diabetes and microalbuminuria. Kidney Int. 2005 Sep;68(3):1190-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary urinary albumin excretion rate
Secondary ambulatory blood pressure
Secondary glomerular filtration rate
Secondary serum potassium
Secondary serum creatinine
Secondary lipids
Secondary renin
Secondary aldosterone
Secondary NT-proBNP
Secondary markers of endothelial function
Secondary markers of inflammation
Secondary genotypes with possible implications for the risk of cardiovascular disease
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