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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00133094
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of atherosclerosis and/or diabetes mellitus
2. Males age 45-70
3. Females age 55-70, at least 1 year post-menopausal
4. No contraindication to HMG-Co A inhibitor therapy
5. No administration of lipid lowering agents, except simvistatin less than or equal to 10 mg/day
6. TSH level greater than 0.34 and less than 5.6 IU
7. Urine protein less than or equal to 300 mg%
8. Lipid profile consistent with Fredrickson type hyperlipidemia: total cholesterol greater than or equal to 140 mg% and less than or equal to 300 mg%; LDL-C greater than or equal to 100 mg%; and triglycerides less than 400 mg%
9. Normal liver function tests (SGOT \< 42 IU; SGPT \<60 IU and CPK \<269 IU)
10. One of the following diagnoses which establishes the presence atherosclerosis, making the subjects candidates for secondary prevention of complications or the presence of diabetes mellitus, which is considered an atherosclerotic equivalent according to the NECP III guidelines: uncomplicated acute myocardial infarction, more than 6 weeks previously; coronary arteriosclerosis (native artery and bypass grafts); prior aortocoronary bypass; prior PTCA; angina pectoris; peripheral vascular disease; or diabetes mellitus
Exclusion Criteria:
1\) Women of childbearing age (2) Chronic liver disease and cirrhosis (3) Viral hepatitis, with residual hepatic dysfunction (4) Active alcohol abuse or dependence within the preceding 3 years (5) Drug abuse with or with out dependence within the preceding 3 years (6) Malignant neoplasms (7) Stroke (8) Dementia (9) Parkinson�s Disease (10) Multiple sclerosis (11) Triglycerides greater than or equal to 400 mg% (12) Other contra-indication to HMG-Co A administration such as cocomitant administration of drugs with known adverse interactions with simvastatin such as amiodarone, cimetidine, cyclosporin, tacrolimus, fibrates, HIV protease inhibitors, nefazodone, erythromycin, telithromycin clarithromycin, verpramil, itraconazole, ketoconozole, fluconazole danazol, or large quantities of grapefruit juice greater than 1 qt/day (13) Concurrent administration of lipid lowering agents or simvastatin at a dose greater than 10 mg/day at the time of entry into the protocol (14) Hypertension with systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg with or without treatment (15) Any chronic illness in which the life expectancy is \<3 years such as oxygen-dependent COPD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT00133094
Study Brief:
Protocol Section:
NCT00133094