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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00596518
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
3. Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications
Exclusion Criteria:
1. Women who are pregnant, nursing or women of childbearing potential
2. Subjects with acute renal disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
77 Years
Study:
NCT00596518
Study Brief:
Protocol Section:
NCT00596518