Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Syndrome, Hypertension

Intervention / Treatment
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* Drug: Irbesartan
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Irbesartan<br>* Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.<br>* Other names: Avapro;|
| Active Comparator: B1<br> | Drug: Hydrochlorothiazide<br>* Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in insulin resistance(MatsudaIndex)Week16 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome