Clinical trial NCT00362258: I PREVENT - Irbesartan In Hypertensive Diabetic Patients
Official title: Irbesartan In Hypertensive Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-08-09
Enrollment: 797
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
timeFrame: During the study conduct
Secondary outcomes:
measure: The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)
timeFrame: During the study conduct
measure: 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)
timeFrame: During the study conduct
measure: Occurrence of any side effect leading to treatment discontinuation.
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Mosaad I Morsi, MBBCh, MSc
role: STUDY_DIRECTOR
References: