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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases
Irbesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014