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:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT00984750
Eligibility Criteria:
Inclusion Criteria:
* Males and females \>40 years old;
* High-risk subjects with type 2 diabetes (WHO criteria);
* High blood pressure (systolic blood pressure \>140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months);
* Serum creatinine concentration \<1.5 mg/dl;
* Patients legally able to give written informed consent to the trial (signed and dated by the patient);
* Written informed consent.
Exclusion criteria:
* Uncontrolled diabetes (glycated hemoglobin \>11%);
* Acute cardiovascular events over the last 3 months;
* Specific contraindications or history of hypersensitivity to the study drugs;
* Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
* Drug or alcohol abuse;
* Any chronic clinical conditions that may affect completion of the trial or confound data interpretation;
* Pregnancy or lactating;
* Women of childbearing potential without following a scientifically accepted form of contraception;
* Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
* Evidence of an uncooperative attitude;
* Any evidence that patient will not be able to complete the trial follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT00984750
Study Brief:
Protocol Section:
NCT00984750