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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03504735
Eligibility Criteria:
Inclusion Criteria:
* BP ≥130/85
* Metabolic syndrome per NCEP-ATP III revised (3/5 criteria)
* Men and women age 40-65
Exclusion Criteria:
* Inability to sign a consent form.
* Unwillingness to complete the protocol for the duration of 15 months
* Unwillingness of primary care physician to participate in the program
* Patients already on hypercholesterolemia agent
* Fasting plasma glucose above 126 mg/dL or current treatment for diabetes.
* If the physician believes the patient should be started on antihypertensive regimen.
* Creatinine clearance \<50ml/min.
* Therapy with anticoagulants
* Pregnant/lactating women (pre-menopausal women should be on birth control pill)
* AST/ALT \> x3 upper limit of normal
* Evidence of cholelithiasis
* Use of oral anticoagulants
* Cancer
* Recent cardiovascular event (\<6months)
* Substance abuse
* Since there is no translator, non-English speaking subjects will not be enrolled in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT03504735
Study Brief:
Protocol Section:
NCT03504735