I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
This study has been completed.
Information provided by:
First received: August 8, 2006
Last updated: May 27, 2011
Last verified: May 2011
- 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- Reduction in left ventricular hypertrophy from baseline values to week 36. [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During all the study conduct ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Drug: Irbesartan (Aprovel)
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.
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