Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564187
• Other study ID #: L_8484
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2007
• Last updated: November 27, 2007
• Start date: February 2003
• Est. completion date: December 2004

Study information

• Verified date: November 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical 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 percentage of patients with SBP < 140 mmHg at 6 and 12 weeks

• To evaluate rate of adverse events during the study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Tunisia	Sanofi-Aventis	Megrine

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		at 6 weeks of treatment
Secondary	• To evaluate the percentage of patients with DBP<90 mmHg		at 6 and 12 weeks
Secondary	• To evaluate rate of adverse events		during the study duration
Secondary	• To evaluate the percentage of patients with SBP<140 mmHg		at 6 and 12 weeks