I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

Study Overview
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Brief Summary
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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.

Official Title
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Irbesartan in Mild to Moderate Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Irbesartan (Aprovel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with proved mild to moderate hypertension. Newly diagnosed naïve hypertensive patients (no prior treatment for hypertension)OR Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion 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 (Systolic Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg). Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus). Patients with HbA1c > 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 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Irbesartan (Aprovel)|Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study. |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any side effects leading to treatment discontinuation. |  | During the study conduct |