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

Tracking Information

First Received Date ^ICMJE

November 20, 2007

Last Updated Date

November 27, 2007

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00564187 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• 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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Irbesartan

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

115

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Tunisia

Administrative Information

NCT ID ^ICMJE

NCT00564187

Responsible Party

Study ID Numbers ^ICMJE

L_8484, -

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Study Director:

Chokri Jeribi

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP