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

NCT ID: NCT00136773

Last Updated: 2011-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-11-30

Brief Summary

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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 Description

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Conditions

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Albuminuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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amlodipine/benazepril

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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CCIB002FUS12

Identifier Type: -

Identifier Source: org_study_id

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