I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Hypertension Clinical Trial

Official title:

Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362037
• Other study ID #: PM_L_0255
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2006
• Last updated: May 27, 2011
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular

Intervention

Drug:
• Irbesartan (Aprovel)
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.

Locations

Country	Name	City	State
Egypt	Sanofi-Aventis Administrative Office	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines		During the study conduct	No
Primary	Reduction in left ventricular hypertrophy from baseline values to week 36.		during the study conduct	No
Secondary	Occurrence of any side effect leading to treatment discontinuation.		During all the study conduct	Yes