The SCCS Polypill Pilot Trial

• Status: Completed
• Trial end date: 2018-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Treatments: Amlodipine; Atorvastatin; Atorvastatin Calcium; Hydrochlorothiazide; Losartan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.