I PREVENT - Irbesartan In Hypertensive Diabetic Patients
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Irbesartan (Aprovel) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Mosaad I Morsi, MBBCh, MSc, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com
Summary
- 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.
Clinical Details
Official title: Irbesartan In Hypertensive Diabetic Patients
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
Secondary outcome: The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)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) Occurrence of any side effect leading to treatment discontinuation.
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Proven Hypertensive Type 2 Diabetic Patients with HbA1c > 6% and ≤ 10% (with or
without microalbuminuria).
- Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension).
OR,
- Patients who were receiving antihypertensive agents (maximum two agents, including one
diuretic) with blood pressure targets achieved, yet, in the investigator's opinion,
those patients would benefit more from switching to the study medication. These
patients will undergo a wash out period for not less than 7 days prior to enrollment.
Exclusion Criteria:
- Severe hypertension (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
- Patients with secondary hypertension.
- Patients with UAE > 200µg / min.
- Patients with HbA1c < 6% or > 10%.
- Significant chronic renal impairment (Serum creatinine > 2. 0 mg/dL).
- Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) > 2. 5 times the upper
limit of the normal range.
- Currently pregnant or lactating females.
- Women of childbearing potential not protected by effective contraceptive method of
birth control and/or who are unwilling or unable to be tested for pregnancy.
- Any patient who is in need for a combination antihypertensive therapy from the start
(from the medical point of view of his/her physician).
- Known hypersensitivity to irbesartan, other ARBs(Angiotensin Receptor Blockers),
hydrochlorothiazide, or other thiazide diuretics.
- Patients with malignancy during the past 5 years, known collagen disease or severe
cardiac, cerebrovascular or gastric disease.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Locations and Contacts
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com
Sanofi-Aventis, Cairo, Egypt; Recruiting
Additional Information
Starting date: February 2006
Last updated: May 27, 2008
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