NCT00283036

Brief Summary

Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 hypertension

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

April 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
Last Updated

April 3, 2008

Status Verified

April 1, 2008

First QC Date

January 26, 2006

Last Update Submit

April 1, 2008

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Arterial Tension

  • Tolerability

Interventions

IrbesartanDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with mild or moderate hypertension defined with arterial diastolic pressure (PAD) at sit position between 90 mmHg and 110 mmHg and arterial systolic pressure (PAS) at sit position between 140 mmHg and 180 mmHg.
  • Patient diagnosed after 3 consultations within 2 months who has never been under treatment and responding to the required conditions for hypertension treatment with irbesartan. This patient must has been under proper but insufficient hygieno dietetic diet

You may not qualify if:

  • Severe Hypertension defined by PAS \> 180mmHg and/or PAD \> 110 mmHg.
  • Isolated systolic Hypertension
  • Secondary Hypertension
  • Arterial stenosis on unique kidney - arterial bilateral kidney stenosis
  • Non-surgically sterilized women or non-menopaused women.
  • Confirmed sodic depletion.
  • Hypersensitivity to Irbesartan.
  • 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

Algiers, Algeria

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nabil BENOUNICHE, MD

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

April 1, 2005

Last Updated

April 3, 2008

Record last verified: 2008-04

Locations

AL(1)