drugset / Trial / NCT00949351

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

Phase 4 Unknown 80 enrolled Lerdsin General Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2009-09
Primary completion
2010-07
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aliskiren Small molecule 300 mg