drugset / Trial / NCT02278471

The SCCS Polypill Pilot Trial

NCT02278471 ↗

Phase 2 Completed 303 enrolled Vanderbilt University
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2015-12
Primary completion
2018-06-27
Completion
2018-06-27

Outcome

Met primary endpoint

paper The mean systolic blood pressure decreased by 9 mm Hg in the polypill group, as compared with 2 mm Hg in the usual-care group PMID 31532959 ↗

paper difference, -7 mm Hg; 95% confidence interval [CI], -12 to -2; P = 0.003 PMID 31532959 ↗

paper LDL cholesterol level decreased by 15 mg per deciliter in the polypill group, as compared with 4 mg per deciliter in the usual-care group PMID 31532959 ↗

paper difference, -11 mg per deciliter; 95% CI, -18 to -5; P<0.001 PMID 31532959 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 2.5 mg —
Subject Atorvastatin Small molecule 10 mg —
Subject Hydrochlorothiazide Unknown 12.5 mg —
Subject Losartan Other / unclassified 25 mg —