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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00110422
First received: May 9, 2005
Last updated: April 7, 2011
Last verified: June 2010
History of Changes

May 9, 2005
April 7, 2011
November 2005
February 2007   (final data collection date for primary outcome measure)
Change from baseline in insulin resistance(MatsudaIndex)Week16
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Complete list of historical versions of study NCT00110422 on ClinicalTrials.gov Archive Site
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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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Hypertension
  • Drug: Irbesartan
    Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
    Other Name: Avapro
  • Drug: Hydrochlorothiazide
    Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.
  • Experimental: A1
    Intervention: Drug: Irbesartan
  • Active Comparator: B1
    Intervention: Drug: Hydrochlorothiazide
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. Epub 2009 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Norway,   Russian Federation,   Spain
 
NCT00110422
CV131-186
Not Provided
Not Provided
Bristol-Myers Squibb
Sanofi
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP