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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| B1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan | Drug | Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in insulin resistance(MatsudaIndex)Week16 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Angers | France | ||||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19929980 | Background | 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. |
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| Hydrochlorothiazide | Drug | Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks. |
|
| 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 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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