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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00562809
First received: November 21, 2007
Last updated: November 26, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: IRBESARTAN
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in the mean SBP [ Time Frame: from baseline to week 18 ]

Secondary Outcome Measures:
  • Change in mean DBP [ Time Frame: from baseline to week 18. ]
  • Changes in mean SBP and DBP [ Time Frame: from baseline to week 10 ]
  • SBP and DBP response and control rates [ Time Frame: at weeks 10 and 18 ]

Enrollment: 1005
Study Start Date: July 2003
Study Completion Date: August 2004
Intervention Details:
    Drug: IRBESARTAN
    150/12.5 mg tablets one or two tablets orally per day
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562809

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Linda Mooney Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562809     History of Changes
Other Study ID Numbers: L_8829
Study First Received: November 21, 2007
Last Updated: November 26, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014