Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00110422

Enrollment

400

Registered

2005-05-10

Start date

2005-11-30

Completion date

2007-02-28

Last updated

2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Metabolic Syndrome

Keywords

Metabolic Syndrome

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.

Interventions

DRUGIrbesartan

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

DRUGHydrochlorothiazide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in insulin resistance(MatsudaIndex)Week16	—

Secondary

Measure	Time frame
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	—

Countries

France, Germany, Italy, Norway, Russia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026