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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
History of Changes
  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:

Drug Information available for: Irbesartan
U.S. FDA Resources

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
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 May 19, 2013