Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria
1 other identifier
interventional
52
1 country
1
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes
Started Sep 2003
Shorter than P25 for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedMay 18, 2006
July 1, 2003
May 1, 2006
May 17, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
urinary albumin excretion rate
Secondary Outcomes (11)
ambulatory blood pressure
glomerular filtration rate
serum potassium
serum creatinine
lipids
- +6 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Steno Diabetes Center
Gentofte Municipality, Copenhagen, 2820, Denmark
Related 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. doi: 10.1111/j.1523-1755.2005.00511.x.
PMID: 16105050RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans-Henrik Parving
Steno Diabetes Center, Gentofte, Denmark
- PRINCIPAL INVESTIGATOR
Kasper Rossing
Steno Diabetes Center, Gentofte, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
September 1, 2003
Study Completion
November 1, 2004
Last Updated
May 18, 2006
Record last verified: 2003-07