Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

NCT ID: NCT00549133

Last Updated: 2007-10-25

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-04-30

Brief Summary

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To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients

Detailed Description

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Conditions

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Hypertension Diabetes Mellitus Type 2

Keywords

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Microalbuminaria in hypertensive patients with type II diabetes mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Irbesartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8
* mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg)

Exclusion Criteria

* congestive heart failure
* azotemia
* insulin dependent diabetes
* liver insufficiency
* pregnancy
* cancer

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Principal Investigators

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Edibe Taylan

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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L_9130

Identifier Type: -

Identifier Source: org_study_id