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

March 8, 2011 updated by: Novartis
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in the urine albumin/creatinine ratio after 52 weeks

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

March 9, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

March 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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