I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Irbesartan (Aprovel) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Mosaad I Morsi, MBBCh, MSc, Study Director, Affiliation: Sanofi-Aventis
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.
Clinical Details
Official title: Irbesartan in Mild to Moderate Hypertensive Patients
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study.
Secondary outcome: Occurrence of any side effects leading to treatment discontinuation.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Cairo, Egypt
Additional Information
Starting date: February 2006
Last updated: May 27, 2008
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