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...
Date First Received: August 25, 2005
Last Updated: March 20, 2008
Verified by: Novartis, March 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2003
Overall Status: Completed
Estimated Enrollment: 888
Brief Summary
Official Title: “Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: amlodipine/benazepril
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in the urine albumin/creatinine ratio after 52 weeks
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 85 Years
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on August 21, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00136773
Study ID Number: CCIB002FUS12
ClinicalTrials.gov Identifier: NCT00136773
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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