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Irbesartan in the Treatment of Hypertensive Patients with Metabolic Syndrome - Article


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Quinapril and Hydrochlorothiazide

Accuretic; Quinaretic 




Clinical Trial: Irbesartan in the Treatment of Hypertensive Patients with Metabolic Syndrome

This study is not yet open for patient recruitment.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb

Purpose

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.

Condition Treatment or Intervention Phase
Metabolic Syndrome X
Hypertension
 Drug: irbesartan
 Drug: hydrochlorothiazide
Phase IV

MedlinePlus related topics:  High Blood Pressure;   Metabolic Syndrome X

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00110422

BMS Call Center      1-866-892-1BMS  Ext. 164 
BMS Call Center Outside the US and Canada      1-215-347-4079  Ext. 164 

More Information

Study ID Numbers:  CV131-186
Record last reviewed:  May 2005
Last Updated:  May 9, 2005
Record first received:  May 9, 2005
ClinicalTrials.gov Identifier:  NCT00110422
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17


Source: ClinicalTrials.gov
Cache Date: May 18, 2005

Resources



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November 27, 2009



Page Updated: June 1, 2005
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