NCT00549133

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

October 24, 2007

Last Update Submit

October 24, 2007

Conditions

HypertensionDiabetes Mellitus Type 2

Keywords

Microalbuminaria in hypertensive patients with type II diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol)

Secondary Outcomes (1)

  • Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.

Interventions

IrbesartanDRUG

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Edibe Taylan

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

October 1, 2003

Study Completion

April 1, 2005

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations

TU(1)