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OpenTrials
Completed

NCT Number: NCT00110422

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irbesartan

Drug

Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.

Other names: Avapro

Hydrochlorothiazide

Drug

Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.

Primary outcomes

  1. Change from baseline in insulin resistance(MatsudaIndex)Week16

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 10, 2005
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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