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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

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. Identifier: NCT00110422
Recruitment Status : Completed
First Posted : May 10, 2005
Last Update Posted : April 15, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Hypertension Drug: Irbesartan Drug: Hydrochlorothiazide Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
Study Start Date : November 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A1 Drug: Irbesartan
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
Other Name: Avapro

Active Comparator: B1 Drug: Hydrochlorothiazide
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.

Primary Outcome Measures :
  1. Change from baseline in insulin resistance(MatsudaIndex)Week16

Secondary Outcome Measures :
  1. Change from baseline in insulin resist-QuickiIndex Week16;Change from baseline in triglyc.,BP,hs-CRP,albumin/creatinine ratio Week16;Changes from baseline-Matsuda,QuickiIndex,BP,triglyc.,hs-CRP&albumin/creatinine ratio Week28

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must be willing and able to provide written informed consent. Subjects must read, sign, and receive a copy of the informed consent prior to any study procedures, including withdrawal of any antihypertensive medication.
  • Males and females >= 18 years of age.
  • Uncontrolled hypertension defined as an average systolic blood pressure >= 140 mmHg and/or an average diastolic blood pressure >= 90 mmHg. This applies to both people not taking any blood pressure medications and people taking just one blood pressure medication.
  • Presenting at least 2 of the following:

    • Obesity;
    • High triglycerides;
    • Low HDL cholesterol;
    • Elevated fasting glucose.

Exclusion Criteria:

  • Women of child bearing potential who are not using adequate birth control.
  • Women who are pregnant or breastfeeding
  • Diabetics
  • Systolic blood pressure >= 180 mmHg.
  • Diastolic blood pressure >= 110 mmHg.
  • Stroke within past 12 months.
  • Myocardial infarction and heart revascularization procedure or acute angina within past 6 months.
  • Moderate to severe heart failure.
  • Significant kidney or liver disease.
  • Cancer in past 5 years.
  • Drug or alcohol abuse.
  • Gout
  • Lupus

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 identifier (NCT number): NCT00110422

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Local Institution
Angers, France
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Nantes, France
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Tierce, France
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Hannover, Germany
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Muenchen, Germany
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Ornbau, Germany
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Rotenburg An De Fluda, Germany
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Tuebingen, Germany
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Villingen-Schwenningen, Germany
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Ancona, Italy
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Chieti Scalo, Italy
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Pisa, Italy
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Ravenna, Italy
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Sassari, Italy
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Oslo, Norway
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Snaroya, Norway
Russian Federation
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Moscow, Russian Federation
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Saratov, Russian Federation
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St. Petersburg, Russian Federation
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Yaroslavl, Russian Federation
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A Coruna, Spain
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Barcelona, Spain
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Granada, Spain
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Sevilla, Spain
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Zaragoza, Spain
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Layout table for additonal information Identifier: NCT00110422    
Other Study ID Numbers: CV131-186
First Posted: May 10, 2005    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: June 2010
Keywords provided by Bristol-Myers Squibb:
Metabolic Syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists