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I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Irbesartan (Aprovel) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Mosaad I Morsi, MBBCh, MSc, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com

Summary

- To evaluate Blood Pressure (BP) reduction to the targeted values (BP ≤ 140/90 mm Hg in

non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients).

- To emphasize and to evaluate the benefit of Irbesartan in the reduction of left

ventricular mass index in hypertensive patients with left ventricular hypertrophy.

- To demonstrate safety of Irbesartan in this population.

Clinical Details

Official title: Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines

Reduction in left ventricular hypertrophy from baseline values to week 36.

Secondary outcome: Occurrence of any side effect leading to treatment discontinuation.

Eligibility

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with proven mild to moderate Hypertension.

- Patients must have left ventricular mass index > 130g/m2 in men, > 100g/m2 in women,

as evidenced by echocardiography before inclusion.

- Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension).

OR,

- Patients who were receiving antihypertensive agents (maximum two agents including one

diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients 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 BP ≥ 180 mm Hg or Diastolic BP ≥ 110 mm Hg).

- Patients with left ventricular ejection fraction < 45%.

- Patients with severe left ventricular hypertrophy.

- Patients with known secondary hypertension (for another cause other than type 2

Diabetes Mellitus).

- Diabetic patients with HbA1c > 10%.

- Significant chronic renal impairment (Serum creatinine > 2. 0 mg/dL).

- Significant liver disease as shown by SGPT/SGOT (ALT/AST) > 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/her 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

Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com

Sanofi-Aventis, Cairo, Egypt; Recruiting
Additional Information

Starting date: February 2006
Last updated: May 27, 2008

Page last updated: August 08, 2008

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