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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT02729766
Eligibility Criteria:
Inclusion Criteria:
* Informed consent as documented by signature
* Age 18 to 65 years
* serum sodium level 135-145mmol/l
* clinically euvolemic status
Exclusion Criteria:
* Known or suspected allergy to trial product or related products
* Pregnancy or breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* untreated hypothyroidism
* cortisol deficiency
* history of heart failure
* liver cirrhosis at any stage
* kidney disease (GFR \<60ml/min)
* epileptic seizures within the last year
* uncontrolled hypertension (systolic blood pressure \>160mmHg)
* Diabetes mellitus type 1 or 2
* BMI \<18 or \>29kg/m2
* other severe disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02729766
Study Brief:
Protocol Section:
NCT02729766