Clinical Trial: Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Brief Summary: Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Change from baseline in the urine albumin/creatinine ratio after 52 weeks
Original Primary Outcome:
Current Secondary Outcome:
- Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
- Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
- Change from baseline in insulin resistance after 52 weeks
- Change from baseline in urine albumin secretion after 52 weeks
- Change from baseline in a marker of heart failure after 52 weeks
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: August 25, 2005
Date Started: April 2003
Date Completion:
Last Updated: March 8, 2011
Last Verified: March 2008
