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I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362037
First Posted: August 9, 2006
Last Update Posted: May 30, 2011
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.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
August 8, 2006
August 9, 2006
May 30, 2011
March 2006
June 2008   (Final data collection date for primary outcome measure)
  • Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines [ Time Frame: During the study conduct ]
  • Reduction in left ventricular hypertrophy from baseline values to week 36. [ Time Frame: during the study conduct ]
  • Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines
  • Reduction in left ventricular hypertrophy from baseline values to week 36.
Complete list of historical versions of study NCT00362037 on ClinicalTrials.gov Archive Site
Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During all the study conduct ]
Occurrence of any side effect leading to treatment discontinuation.
Not Provided
Not Provided
 
I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
  • 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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
Drug: Irbesartan (Aprovel)
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
June 2008
June 2008   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
 
NCT00362037
PM_L_0255
No
Not Provided
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Bristol-Myers Squibb
Study Director: Mosaad I Morsi, MBBCh, MSc Sanofi
Sanofi
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP