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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT01957657
Eligibility Criteria:
Inclusion criteria:
* Healthy volunteers (males and females) or patients with impaired renal function (estimated glomerular filtration rate (eGFR) between 89 and 15) in relatively good health as determined by past medical history, physical examination, vital signs, ECG and laboratory assessments (aside from abnormalities specific for renal impairment)
* Age from 18 to 79 years
* Subjects must be able to understand and comply with study requirements
Exclusion criteria:
* Any relevant deviation from healthy conditions for healthy volunteers
* Subjects with significant diseases other than renal impairment will be excluded. A significant disease is defined as a disease which in the opinion of the investigator:
* put the patient at risk because of participation in the study
* may influence the results of the study
* may influence the patients ability to participate in the study
* is not in a stable condition
* Diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01957657
Study Brief:
Protocol Section:
NCT01957657