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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01850160
Eligibility Criteria:
Inclusion Criteria:
* Patient with diagnosis of arterial hypertension defined as:
* Systolic blood pressure greater or equal to 140 and lower than 180 mmHg
* Diastolic blood pressure greater or equal to 90 and lower than 110 mmHg
* Non controlled patients with antihypertensive treatment (blood pressure values: Systolic blood pressure \> 140 mmHg and/or Diastolic blood pressure \> 90 mmHg) or patients antihypertensive treatment-naïve.
* Likelihood of attending consultations according to the trial chronogram.
* Informed Consent Signature.
Exclusion Criteria:
* Diagnosis of severe or malignant arterial hypertension defined as:
* Systolic blood pressure greater or equal to 180 mmHg
* Diastolic blood pressure greater or equal to 110 mmHg
* Patients with secondary arterial hypertension of any etiology.
* Pregnant women or women with childbearing potential who are not using appropriate contraception methods; women planning to become pregnant during the trial.
* Patients with history of Acute Myocardial Infarction o Angina Pectoris within the 6 months prior to the trial initiation.
* Diagnosis of Cerebrovascular Disease (CVD) o Transient Ischemic Attack (TIA) within the 6 previous months.
* Patients with Severe Renal Disease defined by serum Creatinine levels higher than 1.5 mg/dl.
* Diagnosed or suspected unilateral or bilateral renal artery stenosis.
* History of non remitting cancer within the 5 years prior to the trial initiation.
* Patients with Hypokalemia or Hyperkalemia.
* Patients receiving Valsartan or Chlortalidone during the 14 previous days.
* Patients with known hypersensitivity to Valsartan or Chlorthalidone.
* Unstable patients with antecedent of hospitalization within the 4 days prior to their enrollment in the trial.
* Patients with history of drugs and alcohol abuse within the last year.
* Patients who have taken part in other clinical trial within the 4 weeks prior to the initiation of this research.
* Patients with any other clinical condition that the investigator deems may affect the patient follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01850160
Study Brief:
Protocol Section:
NCT01850160