I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362037
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : May 30, 2011
Bristol-Myers Squibb
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan (Aprovel) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
Study Start Date : March 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines [ Time Frame: During the study conduct ]
  2. Reduction in left ventricular hypertrophy from baseline values to week 36. [ Time Frame: during the study conduct ]

Secondary Outcome Measures :
  1. Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During all the study conduct ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362037

Sanofi-Aventis Administrative Office
Cairo, Egypt
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Mosaad I Morsi, MBBCh, MSc Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00362037     History of Changes
Other Study ID Numbers: PM_L_0255
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action