NCT00562809

Brief Summary

The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,005

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Jul 2003

Shorter than P25 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

July 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

November 21, 2007

Last Update Submit

November 26, 2007

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in the mean SBP

    from baseline to week 18

Secondary Outcomes (3)

  • Change in mean DBP

    from baseline to week 18.

  • Changes in mean SBP and DBP

    from baseline to week 10

  • SBP and DBP response and control rates

    at weeks 10 and 18

Interventions

IRBESARTANDRUG

150/12.5 mg tablets one or two tablets orally per day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have hypertension and uncontrolled SBP on monotherapy.
  • Patients who have read, signed and received a copy of the informed consent prior to any study procedures
  • Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.

You may not qualify if:

  • Any history of secondary hypertension
  • History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months
  • History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

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

  • Linda Mooney

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 22, 2007

Study Start

July 1, 2003

Study Completion

August 1, 2004

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

US(1)