Hypertension
Conditions
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.
Interventions
Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/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
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg. | During the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min) | 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) | During the study conduct |
| Occurrence of any side effect leading to treatment discontinuation. | During the study conduct |
Countries
Egypt
Outcome results
None listed