Status:
COMPLETED
The SCCS Polypill Pilot Trial
Lead Sponsor:
Vanderbilt University
Conditions:
Hypertension
Hyperlipidemia
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
In this study the investigators will examine the effect of the polypill on medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.
Detailed Description
The purpose of this study is to assess if a polypill-based approach to primary CVD prevention is feasible in a low socioeconomic status population. The study will assess whether a polypill approach is...
Eligibility Criteria
Inclusion
- Enrolled at the SCCS site in Mobile, Alabama, obtain care at Franklin Primary Health Center, or live in the surrounding area.
- Aged 45-75 years
- Baseline systolic blood pressure ≥120 mm Hg. In this open-label trial, the study physicians are permitted to prescribe any additional medication deemed appropriate to achieve blood pressure control.
Exclusion
- History of coronary heart disease or stroke
- History of cancer, except for basal cell skin cancer
- History of liver disease, not including chronic, clinically-stable hepatitis
- Laboratory evidence of hepatic dysfunction (an alanine aminotransferase level more than two times the upper limit of the normal range)
- Known renal disease, estimated creatinine clearance \< 60
- Current use of more than 2 anti-hypertensive medications
- LDL cholesterol ≥190 mg/dl
- Insulin-dependent diabetes
- Known intolerance to any of the components of the polypill
- Potassium \<3.4 or \>5.5 mEq/L
- Use of medications that interact with statins, including those affecting the cytochrome P450 system
- Current use of diuretics for indications other than hypertension
- Comorbidities that might be expected to limit lifespan during the 12-month follow-up period
- Inability to provide consent.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2018
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT02278471
Start Date
December 1 2015
End Date
June 27 2018
Last Update
May 14 2021
Active Locations (1)
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1
Franklin Primary Health Center
Mobile, Alabama, United States, 36603