Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Albuminuria
Intervention: amlodipine/benazepril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
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.
Clinical Details
Official title: Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in the urine albumin/creatinine ratio after 52 weeks
Secondary outcome: Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeksChange 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
Eligibility
Minimum age: 21 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Mild to moderate hypertension
- Type 2 diabetes mellitus
- Presence of protein in the urine (albuminuria)
Exclusion Criteria:
- Kidney disease not caused by diabetes or hypertension
- Renal artery stenosis
- Myocardial infarction or stroke within the last 6 months
- Type 1 diabetes mellitus
- Pregnant or lactating females
- Cancer within the last 5 years
Locations and Contacts
Additional Information
Starting date: April 2003
Last updated: March 20, 2008
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