I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients
This study has been completed.
Information provided by:
First received: June 9, 2006
Last updated: March 31, 2011
Last verified: March 2011
- To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients.
- To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc…) at the end of the trial.
|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 Mild to Moderate Hypertensive Patients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of any side effects leading to treatment discontinuation. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Drug: Irbesartan (Aprovel)
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.
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