MedTrace Logo

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

NCT00564187 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2007-11-28

No results posted yet for this study

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

Conditions

Interventions

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

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

Sponsors & Collaborators

Principal Investigators

  • Chokri Jeribi · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Completion
2004-12-31

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564187 on ClinicalTrials.gov