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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT03931369
Eligibility Criteria:
Inclusion Criteria:
* To be 18-85 years old at the date of inclusion, both sex
* to have his/her full-legal capacity and understand the study protocol,
* to be covered by health insurance,
* to give his/her written informed consent
Exclusion Criteria:
* On-going pregnancy,
* women of childbearing age without efficient contraception,
* breastfeeding women,
* all acute (less than 7 days) pathological conditions,
* all active chronic diseases, especially those that could be interfering with water balance and/or thirst and/or renal response to tolvaptan,
* any prohibited treatment since at least 8 days (tolerated : calcium channel blockers, statins, acetaminophen, oral contraception and impregnated sterilets of progesterone are tolerated if necessary),
* hypersensitivity to tolvaptan or its excipients
* severe history of allergy (i.e. dyspnea, edema, cutaneous rash…) secondary to any drug administration
* participants with anuria orurinary pathway obstruction (complete or partial)
* natremia ≤133 mmol/l or ≥145 mmol/l
* hypovolemia
* SGOT, SGPT \> 1.5 fold upper normal values
* estimated GFR (CKD epi) \< 60 ml/min/1.73 m2,)
* current participation to (or being in exclusion period of) another interventional study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03931369
Study Brief:
Protocol Section:
NCT03931369