Hypertension
Conditions
Brief summary
* 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.
Interventions
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.
Sponsors
Bristol-Myers Squibb
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Occurrence of any side effects leading to treatment discontinuation. | During the study conduct |
Countries
Egypt
Outcome results
None listed