Status:
COMPLETED
Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 2 Diabetes
Microalbuminuria
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Aim: The primary aim of our study is to evaluate the antiproteinuric effect of irbesartan 300, 600 and 900 mg once daily in type 2 diabetic patients with microalbuminuria. Secondary to evaluate the e...
Eligibility Criteria
Inclusion
- Type 2 diabetes (WHO criteria) and age above 18 years.
- Persistent microalbuminuria (urinary albumin excretion between 30 and 300 mg/24-h in at least two out of three 24-urinary collections
- Systolic blood pressure \> 110 mmHg
Exclusion
- Serum creatinine \> 150 micromol/l
- Known non-diabetic renal disease
- Pregnancy or fertile women not using adequate contraception (intrauterine device, sterilization or oral anticonception)
- Systolic blood pressure persistently \> 180 mm Hg or \< 100 mm Hg
- Diastolic blood pressure persistently \> 105 mm Hg
- Plasma potassium \> 4.8 mmol/l
- Heart failure, acute myocardial infarction, unstable angina or coronary by-pass surgery within the previous three months.
- Known intolerance to angiotensin II receptor blockers
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00320879
Start Date
September 1 2003
End Date
November 1 2004
Last Update
May 18 2006
Active Locations (1)
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1
Steno Diabetes Center
Gentofte Municipality, Copenhagen, Denmark, 2820