Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Sanofi
• Treatments: Hydrochlorothiazide; Irbesartan

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