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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01100203
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years age ≤ 80 years age
* voluntarily signed informed consent
* 15 ml/min/1,73 m2 ≤ estimated Glomerular Filtration Rate \< 60 ml/min/1,73 m2
* BP ≥ 130/80 mmHg or undergoing anti-hypertensive treatment
Exclusion Criteria:
* p-potassium is \> 5.0 mM
* allergy to contents
* treated with spironolactone
* treated with potent inhibitors of CYP3A4 (see SPC for details)
* treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug
* inborn errors of metabolism (see SPC for details)
* pregnancy or lactation
* fertile woman, not using safe contraception devices
* dementia or other psychiatric disorder, making understanding of the study conditions impossible
* other severe, chronic illness besides CKD, including liver insufficiency, according to investigators' judgement
* vascular surgery including stenting or graft implantation on a. brachialis, aorta or the carotid arteries
* systolic BP \> 200 mmHg
* immeasurable pulse amplitude
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01100203
Study Brief:
Protocol Section:
NCT01100203