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OpenTrials
Completed

NCT Number: NCT00562809

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irbesartan

Drug

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

Primary outcomes

  1. Change in the mean SBP

    Time frame: from baseline to week 18

Secondary outcomes

  1. Change in mean DBP

    Time frame: from baseline to week 18.

  2. Changes in mean SBP and DBP

    Time frame: from baseline to week 10

  3. SBP and DBP response and control rates

    Time frame: at weeks 10 and 18

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Nov 22, 2007
Registry last updated
Nov 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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