The SCCS Polypill Pilot Trial

Completed · Phase 2

Conditions studied: Hypertension, Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT02278471

Run by

Vanderbilt University

People needed

303

Starts

2015-12-01

Expected to finish

2018-06-27

Last updated by the study team

2021-05-14

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Franklin Primary Health Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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