Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
NCT ID: NCT00949351
Last Updated: 2009-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2009-09-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aliskiren
Aliskiren 300mg/d
Aliskiren 300mg/d v.s. placebo for 12wk
Interventions
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Aliskiren 300mg/d
Aliskiren 300mg/d v.s. placebo for 12wk
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \<30yrs-70yrs\>
* Overt proteinuria (Urinary protein creatinine ratio \> 200mg/g 2 times or more during past 6 Mo)
* Scr \< 2.5 mg/dL
* HbA1C \< 7.5
* Systolic blood pressure \> 160 mmHg without antihypertensive drugs or \> 140 with antihypertensive drug
* No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)
* No hospitalization within 1 yr except for elective surgery
Exclusion Criteria
* Non adherence to protocol
* Intolerable to ACEI or ARB during run-in
* Abnormal liver function test at the run-in period
* Rapid declining renal function (SCr increase \> 40%) during run-in
* Hyperkalemia (serum K \> 5.5 mEq/L at randomization)
* Malignancy detected o
* SBP lower than 110 mmHg (at randomization)
30 Years
70 Years
ALL
No
Sponsors
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Lerdsin General Hospital
OTHER
Responsible Party
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Lerdsin General Hospital
Locations
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Lerdsin General Hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Krissanapong Manotham, Dr
Role: primary
Tanaporn Ratanasuwan, Dr
Role: backup
Other Identifiers
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Lerdsin 36/52
Identifier Type: -
Identifier Source: org_study_id