ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

This study has been completed.

Sponsors and Collaborators: Sanofi-Aventis
Bristol-Myers Squibb
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00335673
  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 IV

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Hydrochlorothiazide    Irbesartan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Irbesartan in Mild to Moderate Hypertensive Patients

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:   1754
Study Start Date:   February 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    
      Cairo, Egypt

Sponsors and Collaborators
Sanofi-Aventis
Bristol-Myers Squibb

Investigators
Study Director:     Mosaad I Morsi, MBBCh, MSc     Sanofi-Aventis    
  More Information


Responsible Party:   sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:   IRBES_L_00165
First Received:   June 9, 2006
Last Updated:   May 27, 2008
ClinicalTrials.gov Identifier:   NCT00335673
Health Authority:   Egypt: Ministry of Health and Population

Study placed in the following topic categories:
Irbesartan
Vascular Diseases
Angiotensin II
Hydrochlorothiazide
Hypertension

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

ClinicalTrials.gov processed this record on October 14, 2008




Links to all studies - primarily for crawlers