Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Hypertension Clinical Trial

Official title:

Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110422
• Other study ID #: CV131-186
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2005
• Last updated: April 7, 2011
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: June 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Irbesartan
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
• Hydrochlorothiazide
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.

Locations

Country	Name	City	State
France	Local Institution	Angers
France	Local Institution	Nantes
France	Local Institution	Tierce
Germany	Local Institution	Hannover
Germany	Local Institution	Muenchen
Germany	Local Institution	Ornbau
Germany	Local Institution	Rotenburg An De Fluda
Germany	Local Institution	Tuebingen
Germany	Local Institution	Villingen-Schwenningen
Italy	Local Institution	Ancona
Italy	Local Institution	Chieti Scalo
Italy	Local Institution	Pisa
Italy	Local Institution	Ravenna
Italy	Local Institution	Sassari
Norway	Local Institution	Oslo
Norway	Local Institution	Snaroya
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	Yaroslavl
Spain	Local Institution	A Coruna
Spain	Local Institution	Barcelona
Spain	Local Institution	Granada
Spain	Local Institution	Sevilla
Spain	Local Institution	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Sanofi

Countries where clinical trial is conducted

France,  Germany,  Italy,  Norway,  Russian Federation,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin resistance(MatsudaIndex)Week16
Secondary	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

External Links

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