HypertensionPhase 4NCT00564187
Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice
A Phase 4 study testing Irbesartan in people with Hypertension, run by Sanofi at 1 site in Tunisia.
Trial summary
Primary: To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks) Secondary: To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks To evaluate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTunisia
- Study dates
- Feb 2003to Dec 2004
- 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
- Mild to Moderate hypertension (90mmHg<DBP<110mmHg and 140mmHg<SBP<180mmHg)
- Or new diagnosed hypertension (after 2 visits within 1 month), never treated before and responding to required conditions for a treatment with irbesartan, after an adapted but insufficient diet
- Or a patient having already been treated with a non-satisfying antihypertensive treatment stopped since at least 2 weeks before the inclusion
- A minimum exam labs as required by WHO-ISH within the month before the inclusion
Who cannot join
- Severe Arterial Hypertension (PAS > than or = to 180 mm Hg or PAD > than or = to 110 mmHg)
- Isolated Systolic Hypertension
- Secondary Hypertension
- Bilateral renal arterial stenosis or renal arterial stenosis
- Non surgically sterilised woman or non post-menopausal woman
- Confirmed sodium depletion
- Irbesartan hypersensitivity
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicentric, Randomized, Open, Comparative Phase IV Study Evaluating the Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice
Primary:
- To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks)
Secondary:
- To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks
- To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks
- To evaluate rate of adverse events during the study
- Conditions
- Hypertension
- Being tested
- Irbesartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Irbesartan: 150mg tablets
Dosage: Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
- 150mg/day for normalized patients and patients responding non normalized randomized in the group A
IrbesartanDrug
Irbesartan: 150mg tablets
Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
- Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
• 150mg/day for normalized patients and patients responding non normalized randomized in the group A Receives: Drug: Irbesartan |
| 2 | Active comparator | • Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized (schema N°1: maintenance 150mg/day, schema n°2: 300mg/day for 6 more weeks)
Measured: at 6 weeks of treatment
Secondary outcomes (3)
• To evaluate the percentage of patients with DBP<90 mmHg
Measured: at 6 and 12 weeks
• To evaluate rate of adverse events
Measured: during the study duration
• To evaluate the percentage of patients with SBP<140 mmHg
Measured: at 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startFeb 2003
- Study completionDec 2004
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
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Chokri Jeribi, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564187
- Sponsor's protocol ID
- L_8484
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 28 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Randomized, Open, Comparative Phase IV Study Evaluating the Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice
- ClinicalTrials.gov ID
- NCT00564187
- Acronym / sponsor ID
- L_8484
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2003
- Study completion
- Dec 2004 (actual)
- First posted
- 27 Nov 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 efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks)
Secondary:
- To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks
- To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks
- To evaluate rate of adverse events during the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: IrbesartanUntil 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks: • 150mg/day for normalized patients and patients responding non normalized randomized in the group A |
| 2 | Active comparator | Drug: Irbesartan• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to Moderate hypertension (90mmHg<DBP<110mmHg and 140mmHg<SBP<180mmHg)
- Or new diagnosed hypertension (after 2 visits within 1 month), never treated before and responding to required conditions for a treatment with irbesartan, after an adapted but insufficient diet
- Or a patient having already been treated with a non-satisfying antihypertensive treatment stopped since at least 2 weeks before the inclusion
- A minimum exam labs as required by WHO-ISH within the month before the inclusion
Key exclusion criteria (8 listed)
- Severe Arterial Hypertension (PAS > than or = to 180 mm Hg or PAD > than or = to 110 mmHg)
- Isolated Systolic Hypertension
- Secondary Hypertension
- Bilateral renal arterial stenosis or renal arterial stenosis
- Non surgically sterilised woman or non post-menopausal woman
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 |
|---|---|---|
| IrbesartanIrbesartan: 150mg tablets Dosage: Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks: • 150mg/day for normalized patients and patients responding non normalized randomized in the group A | Drug | 1 |
| IrbesartanIrbesartan: 150mg tablets Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks: • Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B | Drug | 2 |
Primary outcome
To Evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized (schema N°1: maintenance 150mg/day, schema n°2: 300mg/day for 6 more weeks)
Time frame: at 6 weeks of treatment
3 secondary outcomes
• To evaluate the percentage of patients with DBP<90 mmHg
Time frame: at 6 and 12 weeks
• To evaluate rate of adverse events
Time frame: during the study duration
• To evaluate the percentage of patients with SBP<140 mmHg
Time frame: at 6 and 12 weeks
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 28 Nov 2007.
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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.
Chokri Jeribi study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irbesartan in people with Hypertension, run by Sanofi at 1 site in Tunisia.
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 4 inclusion and 8 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 28 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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?
To Evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized (schema N°1: maintenance 150mg/day, schema n°2: 300mg/day for 6 more weeks) (time frame: at 6 weeks of treatment). 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 28 Nov 2007.