I PREVENT - Irbesartan In Hypertensive Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT00362258|
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : April 4, 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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Irbesartan (Aprovel)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||797 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Irbesartan In Hypertensive Diabetic Patients|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
- Drug: Irbesartan (Aprovel)
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.
- Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg. [ Time Frame: During the study conduct ]
- The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min) [ Time Frame: During the study conduct ]
- 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 ]
- Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During 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): NCT00362258
|Sanofi-Aventis Administrative Office|
|Study Director:||Mosaad I Morsi, MBBCh, MSc||Sanofi|