I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
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|ClinicalTrials.gov Identifier: NCT00362037|
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : May 30, 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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Irbesartan (Aprovel)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||281 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Drug: Irbesartan (Aprovel)
- 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 ]
- Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During all the study conduct ]
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 ClinicalTrials.gov identifier (NCT number): NCT00362037
|Sanofi-Aventis Administrative Office|
|Study Director:||Mosaad I Morsi, MBBCh, MSc||Sanofi|