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

Sponsor:	Sanofi-Aventis
Collaborator:	Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00564187

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Irbesartan	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Irbesartan

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

• 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 ]

Enrollment:	115
Study Start Date:	February 2003
Study Completion Date:	December 2004

Arms	Assigned Interventions
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	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
Active Comparator: 2 • Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B	Drug: 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

Arms

Assigned Interventions

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

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

Active Comparator: 2

• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B

Drug: 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564187

Locations

Tunisia
Sanofi-Aventis
Megrine, Tunisia

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Study Director:

Chokri Jeribi

Sanofi-Aventis

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00564187 History of Changes
Other Study ID Numbers:	L_8484
Study First Received:	November 20, 2007
Last Updated:	November 27, 2007
Health Authority:	Tunisia: Office of Pharmacies and Medicines

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012