Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Albuminuria Clinical Trial

Official title:

Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136773
• Other study ID #: CCIB002FUS12
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2005
• Last updated: March 8, 2011
• Start date: April 2003
• Est. completion date: November 2005

Study information

• Verified date: March 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: November 2005
• Est. primary completion date: October 2005
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• amlodipine/benazepril

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the urine albumin/creatinine ratio after 52 weeks
Secondary	Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio = 300 µg/mg creatinine) after 52 weeks
Secondary	Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
Secondary	Change from baseline in insulin resistance after 52 weeks
Secondary	Change from baseline in urine albumin secretion after 52 weeks
Secondary	Change from baseline in a marker of heart failure after 52 weeks