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I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Irbesartan (Aprovel)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

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 Measures

Occurrence of any side effect leading to treatment discontinuation.

Full Information

First Posted
August 8, 2006
Last Updated
May 27, 2011
Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00362037
Brief Title
I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
Official Title
Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Irbesartan (Aprovel)
Intervention Description
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.
Primary Outcome Measure Information:
Title
Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines
Time Frame
During the study conduct
Title
Reduction in left ventricular hypertrophy from baseline values to week 36.
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
Occurrence of any side effect leading to treatment discontinuation.
Time Frame
During all the study conduct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mosaad I Morsi, MBBCh, MSc
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

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