Official Title: “Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Irbesartan
  • Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
• Drug: Hydrochlorothiazide
  • Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A1
• Active Comparator: B1

Primary Measures

• Change from baseline in insulin resistance(MatsudaIndex)Week16

Secondary 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00110422

Study ID Number: CV131-186

ClinicalTrials.gov Identifier: NCT00110422

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm