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OpenTrials
Completed

NCT Number: NCT00564187

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Mégrine, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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)

    Time frame: at 6 weeks of treatment

Secondary outcomes

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

    Time frame: at 6 and 12 weeks

  2. • To evaluate rate of adverse events

    Time frame: during the study duration

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

    Time frame: at 6 and 12 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Nov 27, 2007
Registry last updated
Nov 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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