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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00562809
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : November 27, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: IRBESARTAN Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1005 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2003
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Intervention Details:
    Drug: IRBESARTAN
    150/12.5 mg tablets one or two tablets orally per day

Outcome Measures

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00562809     History of Changes
Other Study ID Numbers: L_8829
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007

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