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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Hypertension

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Irbesartan
Hydrochlorothiazide
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A1

B1

Arm Description

Outcomes

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

Full Information

First Posted
May 9, 2005
Last Updated
April 7, 2011
Sponsor
Bristol-Myers Squibb
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00110422
Brief Title
Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
Official Title
Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Sanofi

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypertension
Keywords
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Title
B1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Other Intervention Name(s)
Avapro
Intervention Description
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Description
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in insulin resistance(MatsudaIndex)Week16
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Angers
Country
France
Facility Name
Local Institution
City
Nantes
Country
France
Facility Name
Local Institution
City
Tierce
Country
France
Facility Name
Local Institution
City
Hannover
Country
Germany
Facility Name
Local Institution
City
Muenchen
Country
Germany
Facility Name
Local Institution
City
Ornbau
Country
Germany
Facility Name
Local Institution
City
Rotenburg An De Fluda
Country
Germany
Facility Name
Local Institution
City
Tuebingen
Country
Germany
Facility Name
Local Institution
City
Villingen-Schwenningen
Country
Germany
Facility Name
Local Institution
City
Ancona
Country
Italy
Facility Name
Local Institution
City
Chieti Scalo
Country
Italy
Facility Name
Local Institution
City
Pisa
Country
Italy
Facility Name
Local Institution
City
Ravenna
Country
Italy
Facility Name
Local Institution
City
Sassari
Country
Italy
Facility Name
Local Institution
City
Oslo
Country
Norway
Facility Name
Local Institution
City
Snaroya
Country
Norway
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
Saratov
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslavl
Country
Russian Federation
Facility Name
Local Institution
City
A Coruna
Country
Spain
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Granada
Country
Spain
Facility Name
Local Institution
City
Sevilla
Country
Spain
Facility Name
Local Institution
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19929980
Citation
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.
Results Reference
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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

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