Status:
COMPLETED
I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hypertension
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
* 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 ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
1630 Patients enrolled
Trial Details
Trial ID
NCT00335673
Start Date
February 1 2006
End Date
November 1 2006
Last Update
April 1 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Cairo, Egypt