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

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ClinicalTrials.gov Identifier: NCT00564187
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : November 28, 2007
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2003
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arm Intervention/treatment
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





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564187


Locations
Tunisia
Sanofi-Aventis
Megrine, Tunisia
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Chokri Jeribi Sanofi

ClinicalTrials.gov Identifier: NCT00564187     History of Changes
Other Study ID Numbers: L_8484
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: November 28, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action