Metabolic SyndromePhase 4NCT00110422
Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
A Phase 4 study testing Irbesartan and Hydrochlorothiazide in people with Metabolic Syndrome and Hypertension, run by Bristol-Myers Squibb at 25 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Hypertension
- What is being tested?
- Irbesartan and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 25 sitesin 6 countries
- Study dates
- Nov 2005to Feb 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
Germany6 sites
Local Institution
Hanover
Local Institution
München
Local Institution
Ornbau
Local Institution
Rotenburg An de Fluda
Local Institution
Tübingen
Local Institution
Villingen-Schwenningen
Italy5 sites
Local Institution
Ancona
Local Institution
Chieti Scalo
Local Institution
Pisa
Local Institution
Ravenna
Local Institution
Sassari
Spain5 sites
Local Institution
A Coruña
Local Institution
Barcelona
Local Institution
Granada
Local Institution
Seville
Local Institution
Zaragoza
Russia4 sites
Local Institution
Moscow
Local Institution
Saint Petersburg
Local Institution
Saratov
Local Institution
Yaroslavl
France3 sites
Local Institution
Angers
Local Institution
Nantes
Local Institution
Tiercé
About this study
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.
- Conditions
- Metabolic Syndrome, Hypertension
- Being tested
- Irbesartan, Hydrochlorothiazide
- Keywords
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Also called Avapro
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
HydrochlorothiazideDrug
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: Irbesartan |
| B1 | Active comparator | Not described Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in insulin resistance(MatsudaIndex)Week16
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110422
- Sponsor's protocol ID
- CV131-186
- Status last verified
- Jun 2010
- First submitted
- 9 May 2005
- Last updated
- 15 Apr 2011
- Results posted
- No
Publications
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.
PubMed 19929980
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00110422
- Acronym / sponsor ID
- CV131-186
- Conditions
- Metabolic Syndrome, Hypertension
- Keywords
- Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Nov 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 10 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Irbesartan |
| B1 | Active comparator | Drug: Hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrbesartanAlso: AvaproTablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks. | Drug | A1 |
| HydrochlorothiazideTablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks. | Drug | B1 |
Primary outcome
Change from baseline in insulin resistance(MatsudaIndex)Week16
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
- Background: PubMed 19929980Parhofer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irbesartan and Hydrochlorothiazide in people with Metabolic Syndrome and Hypertension, run by Bristol-Myers Squibb at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Italy, Spain, Russia, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in insulin resistance(MatsudaIndex)Week16. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.