HypertensionPhase 4NCT00529750
Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension
A Phase 4 study testing IRBESARTAN and Atenolol in people with Hypertension, run by Sanofi.
Trial summary
Primary: To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome. Secondary: To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome. To correlate the oxidative stress status with endothelial function in these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- IRBESARTAN and Atenolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Jan 2005
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension grade 1 or 2
- With at least two of the following criteria for the diagnosis of metabolic syndrome:
- Body mass index > or = 25 kg/m2 AND waist circumference > or = 100 cm.
- Dyslipidemia (triglycerides fasting serum levels > or = 200 mg/dL OR HDL serum levels < or = 40 mg/dL)
- Fasting serum glucose > or = 110 mg/dL but < 126 mg/dL
Who cannot join
- Known hypersensitivity to Irbesartan
- Hypertension grade 3
- History of clinical vascular events such as TIAs, stroke, peripheral arterial disease
- Coronary artery disease
- Renal insufficiency (creatinine serum levels > or = 1.2 mg/dL)
- Presence of clinical heart failure
Show all 13Show fewer
- Asthma and COPD
- Valvular cardiopathy clinically relevant
- Current therapy with antioxidant drugs, statins
- Therapy with AIIRA for at least 3 months during the last semester
- Presence of any acute illness or major trauma in the last 8 weeks
- History of a chronic inflammatory disease such as rheumatoid arthritis, immune disorders or connective tissue disease.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome
Primary:
- To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.
Secondary:
- To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome.
- To correlate the oxidative stress status with endothelial function in these patients.
- To evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function .
- To correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.
- Conditions
- Hypertension
- Being tested
- IRBESARTAN, Atenolol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRBESARTANDrug
Tablets
AtenololDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan Group | Experimental | 150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks Receives: Drug: IRBESARTAN |
| Atenolol Group | Active comparator | 50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks. Receives: Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.
Measured: at baseline and at the end of the study-12th wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startJul 2002
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Juan Carlos Gomez, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529750
- Sponsor's protocol ID
- L_8261
- Status last verified
- Jan 2011
- First submitted
- 12 Sep 2007
- Last updated
- 12 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00529750
- Acronym / sponsor ID
- L_8261
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 14 Sep 2007 (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.
Primary:
- To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.
Secondary:
- To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome.
- To correlate the oxidative stress status with endothelial function in these patients.
- To evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function .
- To correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irbesartan Group | Experimental | Drug: IRBESARTAN150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks |
| Atenolol Group | Active comparator | Drug: Atenolol50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hypertension grade 1 or 2
- With at least two of the following criteria for the diagnosis of metabolic syndrome:
Key exclusion criteria (13 listed)
- Known hypersensitivity to Irbesartan
- Hypertension grade 3
- History of clinical vascular events such as TIAs, stroke, peripheral arterial disease
- Coronary artery disease
- Renal insufficiency (creatinine serum levels > or = 1.2 mg/dL)
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 |
|---|---|---|
| IRBESARTANTablets | Drug | Irbesartan Group |
| AtenololTablets | Drug | Atenolol Group |
Primary outcome
Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.
Time frame: at baseline and at the end of the study-12th wk
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 12 Jan 2011.
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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.
Juan Carlos Gomez study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IRBESARTAN and Atenolol in people with Hypertension, run by Sanofi.
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 5 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 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound. (time frame: at baseline and at the end of the study-12th wk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2011.