Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Phase 4

Completed

• Conditions: Metabolic Syndrome; Hypertension
• Interventions: Drug: Irbesartan; Drug: Hydrochlorothiazide

• Registration Number: NCT00110422
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-05-09
• Study First Submitted QC: 2005-05-09
• Study First Posted: 2005-05-10
• Study Start: 2005-11
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Disposition First Submitted: 2010-02-15
• Disposition First Submitted QC: 2010-02-15
• Disposition First Posted: 2010-02-17
• Status Verified: 2010-06
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Irbesartan	-
B1	Hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in insulin resistance(MatsudaIndex)Week16

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇪🇸 Zaragoza, Spain