Clinical trial NCT00110422: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Hypertension
Keywords: Metabolic Syndrome
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2005-05-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in insulin resistance(MatsudaIndex)Week16
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Angers
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Tierce
country: France
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Ornbau
country: Germany
facility: Local Institution
city: Rotenburg An De Fluda
country: Germany
facility: Local Institution
city: Tuebingen
country: Germany
facility: Local Institution
city: Villingen-Schwenningen
country: Germany
facility: Local Institution
city: Ancona
country: Italy
facility: Local Institution
city: Chieti Scalo
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Ravenna
country: Italy
facility: Local Institution
city: Sassari
country: Italy
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Snaroya
country: Norway
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Granada
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.