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Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy

NCT00949351 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-07-30

No results posted yet for this study

Summary

Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.

Conditions

  • Type 2 Diabetes With Nephropathy

Interventions

DRUG

Aliskiren 300mg/d

Aliskiren 300mg/d v.s. placebo for 12wk

Sponsors & Collaborators

  • Lerdsin General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-07-31
Completion
2010-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949351 on ClinicalTrials.gov