NCT02278471

The SCCS Polypill Pilot Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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 associated with better cardiovascular risk factor control compared with usual care. The polypill will be supplied as a compounded pill containing atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. The medications in the polypill have been extensively evaluated individually and in combination. Each of the medications in the polypill is approved by the United States Food and Drug Administration (FDA) and widely administered in the US for the treatment of and prevention of cardiovascular disease. The doses of each component medication included in the polypill are low, which should minimize the chance of any potential side-effects. In this study we assess medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span, in subjects taking the polypill versus subjects under usual care.

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-06-27
• Completion: 2018-06-27
• First posted: 2014-10-30
• Last updated: 2021-05-14
• Results posted: 2019-10-01

Locations

1 site across 1 country: United States