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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
This study has been completed.
Sponsors and Collaborators: Bristol-Myers Squibb
Sanofi-Aventis
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00110422
  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 Intervention Phase
Metabolic Syndrome
Hypertension
Drug: Irbesartan
Drug: Hydrochlorothiazide
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Irbesartan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change from baseline in insulin resistance(MatsudaIndex)Week16

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: November 2005
Arms Assigned Interventions
A1: Experimental Drug: Irbesartan
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
B1: Active Comparator Drug: Hydrochlorothiazide
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Gout
  • Lupus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110422

Locations
France
Local Institution
Angers, France
Local Institution
Nantes, France
Local Institution
Tierce, France
Germany
Local Institution
Muenchen, Germany
Local Institution
Hannover, Germany
Local Institution
Villingen-Schwenningen, Germany
Local Institution
Ornbau, Germany
Local Institution
Tuebingen, Germany
Local Institution
Rotenburg An De Fluda, Germany
Italy
Local Institution
Ancona, Italy
Local Institution
Chieti Scalo, Italy
Local Institution
Pisa, Italy
Local Institution
Ravenna, Italy
Local Institution
Sassari, Italy
Norway
Local Institution
Oslo, Norway
Local Institution
Snaroya, Norway
Russian Federation
Local Institution
St. Petersburg, Russian Federation
Local Institution
Saratov, Russian Federation
Local Institution
Moscow, Russian Federation
Local Institution
Yaroslavl, Russian Federation
Spain
Local Institution
Zaragoza, Spain
Local Institution
Barcelona, Spain
Local Institution
Sevilla, Spain
Local Institution
A Coruna, Spain
Local Institution
Granada, Spain
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi-Aventis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Study ID Numbers: CV131-186
Study First Received: May 9, 2005
Last Updated: June 27, 2008
ClinicalTrials.gov Identifier: NCT00110422  
Health Authority: United States: Food and Drug Administration;   France: Ministry of Health

Keywords provided by Bristol-Myers Squibb:
Metabolic Syndrome

Study placed in the following topic categories:
Irbesartan
Vascular Diseases
Angiotensin II
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:
Disease
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Pathologic Processes
Natriuretic Agents
Therapeutic Uses
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009