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A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

NCT ID: NCT00171119

Last Updated: 2008-12-17

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.

Detailed Description

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Conditions

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Hypertension Diabetic Nephropathy

Keywords

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HYPERTENSION DIABETES MELLITUS TYPE II VALSARTAN BENAZAPRIL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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valsartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria
* patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry
* patients who give written, signed, informed consent.
* patients with/without mild /moderate hypertension.
* patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment.
* patients without any accompanying systemic disease

Exclusion Criteria

* pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception
* patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CVAL489ATR05

Identifier Type: -

Identifier Source: org_study_id