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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT03459560
Eligibility Criteria:
Inclusion Criteria:
* 50-79 years old
* Enrollment in the Pars Cohort Study
Exclusion Criteria:
1. Not consenting to participate in the study
2. Hypersensitivity to any of PolyPill components:
1. Hypersensitivity to Non-steroidal anti-inflammatory agents
2. Hypersensitivity to statins
3. Hypersensitivity to hydrochlorothiazide or sulfonamides
4. Hypersensitivity to enalapril and valsartan
3. Past medical history of angioedema
4. Medical history of GI bleeding or peptic ulcer in the last 3 months
5. Pregnancy or lactation
6. Bleeding disorders such as hemophilia
7. Receiving regular anticoagulation therapy
8. Alcohol consumption greater than 40gr/week
9. Advanced liver disease
10. Uncontrolled seizures
11. Asthma with any of the following criteria present:
1. Daily symptoms
2. Asthmatic attacks waking the patient from sleep more than once a week
3. History of nasal polyps
4. Aspirin sensitive asthma
5. Presence of rhinitis symptoms not due to infection
12. Past medical history of gout
13. Serum creatinine values above 2 mg/dL
14. Glomerular Filtration Rate (GFR) below 30 mL/min
15. Hemoglobin concentrations below 11 g/dL for males and 10 g/dL for females
16. BP \< 90/60 mmHg
17. Debilitating medical/mental disorders affecting compliance (including psychosis, disabilities, and blindness)
18. Past medical history of stroke
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
79 Years
Study:
NCT03459560
Study Brief:
Protocol Section:
NCT03459560