NCT00334581

Brief Summary

Primary objective:

  • To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria. Secondary objectives:
  • To determine how well irbesartan 300mg is tolerated versus 150mg
  • To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

2.1 years

First QC Date

June 7, 2006

Last Update Submit

September 14, 2009

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • The difference of urinary albumin excretion rate change

    at week 24

Secondary Outcomes (2)

  • Percentage of patients reaching target BP of 130/80mmHg

    At week 24

  • Adverse events

    From the beginning to the end of the study

Study Arms (2)

1

EXPERIMENTAL

Irbesartan 150mg

Drug: Irbesartan

2

EXPERIMENTAL

Irbesartan 300mg

Drug: Irbesartan

Interventions

IrbesartanDRUG

Administration throughout the study period

1

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
  • Blood pressure of \< 180/110mmHg at baseline
  • Normal serum creatinine

You may not qualify if:

  • Type 1 diabetes
  • Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
  • Pregnant or lactating women
  • Severe hypertension
  • Overt nephropathy
  • Allergy to study drug
  • 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 Administrative Office

Shanghai, China

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

  • Bruno Jolain

    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

June 7, 2006

First Posted

June 8, 2006

Study Start

May 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

CN(1)