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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT01191450
Eligibility Criteria:
Inclusion Criteria:
* Systolic blood pressure between 140 mmHg - 159 mmHg
* Diastolic blood pressure between 90 mmHg - 99 mmHg
* Subject aged ≥ 60 years old
* Be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project.
* Diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration.
Exclusion Criteria:
* Any serious or severe clinically significant medical condition.
* Psychiatric or neurological diseases
* A condition that, as per Principal Investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient.
* Participation in any other investigational study within 12 months prior to Visit 1.
* Known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study
* Routine prior use of diuretics
* Oral anticoagulant use
* Fast glycemia \> 150 mg/dL
* Medical treatment, not related to study, scheduled for the clinical trial duration; except non-serious, controlled comorbidities in current medical follow-up.
* Expected onset of additional antihypertensive drug after the study onset
* Acute myocardial infarction within last 6 months
* Prior decompensated coronary artery disease
* Known thyroid, renal or liver dysfunction, at investigator's discretion
* Obesity - body mass index (BMI) \> 33 kg/m2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01191450
Study Brief:
Protocol Section:
NCT01191450