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

NCT00564187 | Completed Phase 4

• 1 other identifier: L_8484
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• • To evaluate the percentage of patients with DBP<90 mmHg

  at 6 and 12 weeks

• • To evaluate rate of adverse events

  during the study duration

• • To evaluate the percentage of patients with SBP<140 mmHg

  at 6 and 12 weeks

Study Arms (2)

1

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

Drug: Irbesartan

2

ACTIVE COMPARATOR

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

Drug: Irbesartan

Interventions

Irbesartan DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sanofi-Aventis

Mégrine, Tunisia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Chokri Jeribi

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 27, 2007
• Study Start: February 1, 2003
• Study Completion: December 1, 2004
• Last Updated: November 28, 2007

Record last verified: 2007-11

Locations

TU (1)