I PREVENT - Irbesartan In Hypertensive Diabetic Patients
This study has been completed.
Information provided by:
First received: August 8, 2006
Last updated: April 1, 2011
Last verified: March 2011
- To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.
- To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population.
- To demonstrate the 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 Diabetic Patients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- First detection of overt nephropathy (UAE rate > 200µg / min), in patients with microalbuminuria or at least 30% higher than at baseline value(on at least two consecutive occasions) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Drug: Irbesartan (Aprovel)
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.
Contacts and Locations