Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

NCT ID: NCT00110422

Last Updated: 2011-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A1

Group Type: EXPERIMENTAL

Irbesartan

Intervention Type: DRUG

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

B1

Group Type: ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type: DRUG

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

Interventions

Irbesartan

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

Intervention Type: DRUG

Hydrochlorothiazide

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

Intervention Type: DRUG

Other Intervention Names

Avapro

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Angers, , France

Local Institution

Nantes, , France

Local Institution

Tiercé, , France

Local Institution

Hanover, , Germany

Local Institution

München, , Germany

Local Institution

Ornbau, , Germany

Local Institution

Rotenburg An de Fluda, , Germany

Local Institution

Tübingen, , Germany

Local Institution

Villingen-Schwenningen, , Germany

Local Institution

Ancona, , Italy

Local Institution

Chieti Scalo, , Italy

Local Institution

Pisa, , Italy

Local Institution

Ravenna, , Italy

Local Institution

Sassari, , Italy

Local Institution

Oslo, , Norway

Local Institution

Snaroya, , Norway

Local Institution

Moscow, , Russia

Local Institution

Saint Petersburg, , Russia

Local Institution

Saratov, , Russia

Local Institution

Yaroslavl, , Russia

Local Institution

A Coruña, , Spain

Local Institution

Barcelona, , Spain

Local Institution

Granada, , Spain

Local Institution

Seville, , Spain

Local Institution

Zaragoza, , Spain

Countries

France; Germany; Italy; Norway; Russia; Spain

References

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.

Reference Type: BACKGROUND

PMID: 19929980 (View on PubMed)

Other Identifiers

CV131-186

Identifier Type: -

Identifier Source: org_study_id