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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00564187
First received: November 20, 2007
Last updated: November 27, 2007
Last verified: November 2007
History of Changes
  Purpose

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 Intervention Phase
Hypertension
 Drug: Irbesartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Irbesartan
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • • 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 ]

Enrollment: 115
Study Start Date: February 2003
Study Completion Date: December 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564187

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

No publications provided

ClinicalTrials.gov Identifier: NCT00564187     History of Changes
Other Study ID Numbers: L_8484
Study First Received: November 20, 2007
Last Updated: November 27, 2007
Health Authority: Tunisia: Office of Pharmacies and Medicines

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013