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:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02187757
Eligibility Criteria:
Inclusion Criteria:
Newly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories:
1. Age ≥ 18 years to ≤ 65 years
2. LDL cholesterol levels \>120mg/dl
3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures -
Exclusion Criteria:
1. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.
2. Cardiac status New York Heart Association class III-IV
3. Uncotrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic
4. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
5. Clinically significant peripheral edema
6. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
7. Participants on steroid
8. Pregnancy or lactating women
9. Known hypersensitivity to any of the study drugs
10. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
11. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
12. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
13. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
14. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study
15. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02187757
Study Brief:
Protocol Section:
NCT02187757