The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension

November 26, 2007 updated by: Sanofi

A Multicenter, Open-Label Study Assessing the Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Hypertension Not Controlled by Monotherapy

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.

Study Overview

Status

Completed

Conditions

Hypertension

Intervention / Treatment

Drug: IRBESARTAN

Detailed Description

The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.

Study Type

Interventional

Enrollment (Actual)

1005

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - Bridgewater, New Jersey, United States, 08807
    - Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the mean SBP Time Frame: from baseline to week 18	from baseline to week 18

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in mean DBP Time Frame: from baseline to week 18.	from baseline to week 18.
Changes in mean SBP and DBP Time Frame: from baseline to week 10	from baseline to week 10
SBP and DBP response and control rates Time Frame: at weeks 10 and 18	at weeks 10 and 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Linda Mooney, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria