Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice
NCT ID: NCT00564187
Last Updated: 2007-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
115 participants
INTERVENTIONAL
2003-02-28
2004-12-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
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
Irbesartan
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
2
• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B
Irbesartan
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
Interventions
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Irbesartan
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
Irbesartan
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Sanofi
INDUSTRY
Principal Investigators
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Chokri Jeribi
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Mégrine, , Tunisia
Countries
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Other Identifiers
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L_8484
Identifier Type: -
Identifier Source: org_study_id