- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00564187
Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Megrine, Tunisia
- Sanofi-Aventis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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: 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: 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 |
Active Comparator: 2
• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B
|
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: 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at 6 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• To evaluate the percentage of patients with DBP<90 mmHg
Time Frame: at 6 and 12 weeks
|
at 6 and 12 weeks
|
• To evaluate rate of adverse events
Time Frame: during the study duration
|
during the study duration
|
• To evaluate the percentage of patients with SBP<140 mmHg
Time Frame: at 6 and 12 weeks
|
at 6 and 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Chokri Jeribi, Sanofi
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L_8484
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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