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:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT01556633
Eligibility Criteria:
Inclusion Criteria:
General
* Adult volunteers, aged 19 to 90 years
* Medically stable with no hospitalization for a significant disease in the 3 months before study start
Volunteers on dialysis
* A documented and well-established dialysis therapy
Volunteers with reduced creatinine clearance
* Creatinine clearance from 10 to 30 mL/min
* Stable renal function
Exclusion Criteria:
* Clinically significant and unstable disease (e.g., cardiac, hepatic, pulmonary)
* Medical history of concurrent medical condition that would compromise participation in the study
* Hypotensive episodes or symptoms of fainting, dizziness or lightheadedness in the 4 weeks before screening
* Uncontrolled hypotension or hypertension
* Infection with hepatitis B, hepatitis C or human immunodeficiency virus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
90 Years
Study:
NCT01556633
Study Brief:
Protocol Section:
NCT01556633