Trial | NCT00949351  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    aliskiren ...

  • Study Participants

    80
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.
Study Started
Sep 30
2009
Primary Completion
Jul 31
2010
Anticipated
Study Completion
Sep 30
2010
Anticipated
Last Update
Jul 30
2009
Estimate

Drug Aliskiren 300mg/d

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

  • Other names: Rasilez (Thailand)

Aliskiren Placebo Comparator

Criteria 

Inclusion Criteria:

Type2 diabetes patients
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:

Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
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)
No Results Posted