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 @ 1:30 AM
Ignite Modification Date:
2025-12-25 @ 1:30 AM
NCT ID:
NCT00571194
Eligibility Criteria:
Inclusion Criteria:
1. Patients from 12 months to 18 years of age.
2. Patients with end stage renal disease who receive continuous cycling peritoneal dialysis.
3. signed informed consent
4. Physical exam demonstrates no abnormalities that would make this study medically hazardous to the subject.
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Exclusion Criteria:
1. Any clinically significant unstable medical condition or chronic disease other than those associated with ESRD.
2. Any clinically significant illness within 10 days or receiving single-sdoe of study medication
3. History of rhabdomyolysis
4. Clinically significant liver disease or history of malabsorption or previous gastrointestinal surgery that could effect drug absorption or metabolism.
5. Clinical laboratory abnormalities: Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine phosphokinase(CPK) \> 2.5 times upper limit of normal; hemoglobin \< 8.5 g.dL.
6. Known hypersensitivity to pravastatin
7. Unwilling to have blood samples drawn
8. Has taken a HMG-CoA reductase inhibitor in the last week -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
18 Years
Study:
NCT00571194
Study Brief:
Protocol Section:
NCT00571194