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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

Page last updated: June 20, 2008

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