I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00335673
• Lead Sponsor: Sanofi

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 according to their profile (naïve, switch, patient history, etc...) at the end of the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-06-09
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1630

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study.	During the study conduct

Secondary Outcome Measures

Name	Time	Method
Occurrence of any side effects leading to treatment discontinuation.	During the study conduct

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇬 Cairo, Egypt