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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: May 9, 2005
Last updated: April 7, 2011
Last verified: June 2010
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 Intervention Phase
Metabolic Syndrome Hypertension Drug: Irbesartan Drug: Hydrochlorothiazide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: November 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00110422

Local Institution
Angers, France
Local Institution
Nantes, France
Local Institution
Tierce, France
Local Institution
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
Local Institution
Moscow, Russian Federation
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Saratov, Russian Federation
Local Institution
St. Petersburg, Russian Federation
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Yaroslavl, Russian Federation
Local Institution
A Coruna, Spain
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Barcelona, Spain
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Granada, Spain
Local Institution
Sevilla, Spain
Local Institution
Zaragoza, Spain
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications: Identifier: NCT00110422     History of Changes
Other Study ID Numbers: CV131-186
Study First Received: May 9, 2005
Last Updated: April 7, 2011

Keywords provided by Bristol-Myers Squibb:
Metabolic Syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
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 processed this record on September 19, 2017