Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

NCT00110422 | Completed Phase 4

• 1 other identifier: CV131-186
• Study Type: interventional
• Target: 400
• Locations: 6 countries
• Sites: 25

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.

Conditions

Metabolic Syndrome; Hypertension

Keywords

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline in insulin resistance(MatsudaIndex)Week16

Secondary Outcomes (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

Study Arms (2)

A1

EXPERIMENTAL

Drug: Irbesartan

B1

ACTIVE COMPARATOR

Drug: Hydrochlorothiazide

Interventions

Irbesartan DRUG

Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.

Also known as: Avapro

A1

Hydrochlorothiazide DRUG

Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.

B1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Sanofi: collaborator

Study Sites (25)

Local Institution

Angers, France

Location

Local Institution

Nantes, France

Location

Local Institution

Tiercé, France

Location

Local Institution

Hanover, Germany

Location

Local Institution

München, Germany

Location

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Ornbau, Germany

Location

Local Institution

Rotenburg An de Fluda, Germany

Location

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Tübingen, Germany

Location

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Villingen-Schwenningen, Germany

Location

Local Institution

Ancona, Italy

Location

Local Institution

Chieti Scalo, Italy

Location

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Pisa, Italy

Location

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Ravenna, Italy

Location

Local Institution

Sassari, Italy

Location

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Oslo, Norway

Location

Local Institution

Snaroya, Norway

Location

Local Institution

Moscow, Russia

Location

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Saint Petersburg, Russia

Location

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Saratov, Russia

Location

Local Institution

Yaroslavl, Russia

Location

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A Coruña, Spain

Location

Local Institution

Barcelona, Spain

Location

Local Institution

Granada, Spain

Location

Local Institution

Seville, Spain

Location

Local Institution

Zaragoza, Spain

Location

Related Publications (1)

• Parhofer KG, Birkeland KI, DeFronzo R, Del Prato S, Bhaumik A, Ptaszynska A. Irbesartan has no short-term effect on insulin resistance in hypertensive patients with additional cardiometabolic risk factors (i-RESPOND). Int J Clin Pract. 2010 Jan;64(2):160-8. doi: 10.1111/j.1742-1241.2009.02246.x. Epub 2009 Nov 19.

  PMID: 19929980 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension

Interventions

Irbesartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 9, 2005
• First Posted: May 10, 2005
• Study Start: November 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 15, 2011

Record last verified: 2010-06

Locations

ES (5); NO (2); IT (5); FR (3); DE (6); RU (4)