The SCCS Polypill Pilot Trial

April 18, 2021 updated by: Thomas Wang, Vanderbilt University
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36603
        • Franklin Primary Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Subjects in this arm will not receive any investigational medications. They will remain on the same care that they are use to receiving.
Experimental: Polypill

The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg.

Polypill will be taken once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: 12 months
polypill versus usual care
12 months
Medication Adherence-Percentage of Pills Taken
Time Frame: 12 months
polypill arm-evaluation via pill counts.
12 months
LDL Cholesterol
Time Frame: 12 months
Polypill versus usual care
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: 2 months
polypill versus usual care
2 months
Medication Adherence
Time Frame: 2 months
polypill-percentage of pills taken, evaluated via pill counts
2 months
Drug Metabolite Profile
Time Frame: 12 months
LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.
12 months
LDL Cholesterol
Time Frame: 2 months
polypill versus usual care
2 months
Insulin Resistance
Time Frame: Baseline and 12 months
Measurement of HOMA-IR using fasting glucose and insulin.
Baseline and 12 months
Inflammatory Profile
Time Frame: Baseline and 12 months
Plasma levels of IL-17, IFN-g, IL-6, IL-10, high sensitivity C-reactive protein, TNFa, IL-4.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas J Wang, MD, Vanderbilt Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

June 27, 2018

Study Completion (Actual)

June 27, 2018

Study Registration Dates

First Submitted

October 13, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

April 18, 2021

Last Verified

April 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)

3
Subscribe