Phase 2
Completed N=303
The SCCS Polypill Pilot Trial
Source: ClinicalTrials.gov NCT02278471 ↗Enrolled (actual)
303
Serious AEs
1.7%
Results posted
Oct 2019
Primary outcomePrimary: Systolic Blood Pressure — 138; 131 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure |
133; 128 | — |
| PRIMARY Medication Adherence-Percentage of Pills Taken |
86 | — |
| PRIMARY LDL Cholesterol |
108; 90 | — |
| SECONDARY Systolic Blood Pressure |
133; 128 | — |
| SECONDARY Medication Adherence |
98 | — |
| SECONDARY Drug Metabolite Profile |
— | — |
| SECONDARY LDL Cholesterol |
108; 90 | — |
| SECONDARY Insulin Resistance |
— | — |
| SECONDARY Inflammatory Profile |
— | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02278471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.