Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT00362258
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00362258
Study Brief:
Protocol Section:
NCT00362258