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I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00335673
First received: June 9, 2006
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose
  • To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients.
  • To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc…) at the end of the trial.

Condition Intervention Phase
Hypertension
 Drug: Irbesartan (Aprovel)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Irbesartan in Mild to Moderate Hypertensive Patients

Resource links provided by NLM:

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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of any side effects leading to treatment discontinuation. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]

Enrollment: 1630
Study Start Date: February 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Irbesartan (Aprovel)
    Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with proved mild to moderate hypertension.
  • Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)OR
  • Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

  • Severe hypertension (Systolic Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg).
  • Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus).
  • Patients with HbA1c > 10%.
  • Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
  • Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) > 2.5 times the upper limit of the normal range.
  • Currently pregnant or lactating females.
  • Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
  • Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his physician).
  • Known hypersensitivity to irbesartan, other ARBs (Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
  • Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.

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: NCT00335673

Locations
Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt
Sponsors and Collaborators
Sanofi-Aventis
Bristol-Myers Squibb
Investigators
Study Director: Mosaad I Morsi, MBBCh, MSc Sanofi-Aventis
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00335673     History of Changes
Other Study ID Numbers: IRBES_L_00165
Study First Received: June 9, 2006
Last Updated: March 31, 2011
Health Authority: Egypt: Ministry of Health and Population

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 October 16, 2012