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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT01732718
Eligibility Criteria:
Inclusion Criteria:
1. Sickle cell anemia (HbSS) or Sickle-beta0 thalassemia (HbS-beta0thal) between ages of 18 and 60;
2. albuminuria (micro- or macroalbuminuria, defined as =/\> 30mg/g creatinine);
3. serum alanine aminotransferase (ALT) \</= 2 times upper limits of normal and/or gamma-glutamyl transferase (GGT) \</= 3 times upper limits of normal;
4. platelet count \> 150,000 cu/mm;
5. normal baseline coagulation profile (PT, International Normalized Ratio (INR), and PTT);
6. non-crisis, steady state with no severe pain episodes during the preceding 4 weeks, and no documented infection in the 2 weeks prior to enrollment;
7. ability to understand the requirements of the study;
8. if a woman of childbearing potential, must use an adequate method of contraception; and
9. if receiving hydroxyurea, ACE inhibitors or angiotensin blockers (ARB), should be on a stable dose for at least 3 months.
Exclusion Criteria:
1. hypersensitivity to any component of atorvastatin, or history of adverse reaction to statins;
2. pregnant or breastfeeding;
3. on statin therapy;
4. history of metastatic cancer;
5. current history of alcohol abuse;
6. history of diabetes mellitus or poorly controlled systemic hypertension;
7. end-stage renal disease;
8. total cholesterol level \< 80 mg/dL and LDL cholesterol \> 130 mg/dL;
9. on a chronic transfusion program;
10. ingested any investigational drugs within the past 4 weeks;
11. prior history of any myopathy;
12. allergy to nitroglycerin;
13. taking any of the following drugs: phosphodiesterase-5 inhibitors (e.g., sildenafil), cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g., cyclosporine, protease inhibitors), macrolide antibiotics (e.g., clarithromycin, erythromycin), fibric acid derivatives (e.g. gemfibrozil), niacin, colchicines, antifungal agents (azole derivatives), amiodarone, danazol, daptomycin, diltiazem, verapamil, eltrombopag, everolimus, fosphenytoin, or lanthanum.
Patients will also be encouraged to avoid grape fruit juice and red yeast rice for the duration of the study.
Atorvastatin is contraindicated during pregnancy and breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01732718
Study Brief:
Protocol Section:
NCT01732718