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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06782204
Eligibility Criteria:
Inclusion Criteria:
* Informed of the nature of the study and giving written informed consent before any study assessment is performed,
* Able to understand and communicate effectively with study personnel,
* Male or non-pregnant, non-lactating female patients over 18 years of age,
* A diagnosis of hypertension defined either as:
1. Use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion,
2. In untreated patients: office systolic blood pressure values \>= 140 mmHg and/ or diastolic blood pressure values \>= 90 mmHg,(Williams et al. 2018)
* Have no contraindication for 1 g of oral paracetamol.
Exclusion Criteria:
* Hypersensitivity or idiosyncratic reaction to paracetamol,
* Paracetamol intake in the last seven days before Visit 2,
* Non-steroidal antiinflammatory drug intake,
* Pregnancy or breastfeeding,
* BMI \<18 kg/m2,
* History of clinically significant liver disease or liver injury as indicated by abnormal liver enzymes such as ALT, GGT or serum bilirubin (any single parameter may not exceed 2x upper limit of normal),
* Current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study,
* Hospital da Luz employees, NMS\|FCM employees, medical students at NMS\|FCM and workers or others with a direct dependency on the PI or the sponsor,
* Participation in a clinical study of any investigational product 1 month prior to visit 1 or during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06782204
Study Brief:
Protocol Section:
NCT06782204