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The SCCS Polypill Pilot Trial

Primary Purpose

Hypertension, Hyperlipidemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)

About this trial

This is an interventional prevention trial for Hypertension focused on measuring combination pill, polypill, primary prevention

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Franklin Primary Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Polypill

Arm Description

Subjects in this arm will not receive any investigational medications. They will remain on the same care that they are use to receiving.

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.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure

polypill versus usual care

Medication Adherence-Percentage of Pills Taken

polypill arm-evaluation via pill counts.

LDL Cholesterol

Polypill versus usual care

Secondary Outcome Measures

Systolic Blood Pressure

polypill versus usual care

Medication Adherence

polypill-percentage of pills taken, evaluated via pill counts

Drug Metabolite Profile

LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.

LDL Cholesterol

polypill versus usual care

Insulin Resistance

Measurement of HOMA-IR using fasting glucose and insulin.

Inflammatory Profile

Plasma levels of IL-17, IFN-g, IL-6, IL-10, high sensitivity C-reactive protein, TNFa, IL-4.

Full Information

NCT ID

NCT02278471

First Posted

October 13, 2014

Last Updated

April 18, 2021

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT02278471

Brief Title

The SCCS Polypill Pilot Trial

Official Title

The SCCS Polypill Pilot Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 2015 (Actual)

Primary Completion Date

June 27, 2018 (Actual)

Study Completion Date

June 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Hyperlipidemia

Keywords

combination pill, polypill, primary prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

303 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Subjects in this arm will not receive any investigational medications. They will remain on the same care that they are use to receiving.

Arm Title

Polypill

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)

Primary Outcome Measure Information:

Title

Systolic Blood Pressure

Description

polypill versus usual care

Time Frame

12 months

Title

Medication Adherence-Percentage of Pills Taken

Description

polypill arm-evaluation via pill counts.

Time Frame

12 months

Title

LDL Cholesterol

Description

Polypill versus usual care

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Systolic Blood Pressure

Description

polypill versus usual care

Time Frame

2 months

Title

Medication Adherence

Description

polypill-percentage of pills taken, evaluated via pill counts

Time Frame

2 months

Title

Drug Metabolite Profile

Description

LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.

Time Frame

12 months

Title

LDL Cholesterol

Description

polypill versus usual care

Time Frame

2 months

Title

Insulin Resistance

Description

Measurement of HOMA-IR using fasting glucose and insulin.

Time Frame

Baseline and 12 months

Title

Inflammatory Profile

Description

Plasma levels of IL-17, IFN-g, IL-6, IL-10, high sensitivity C-reactive protein, TNFa, IL-4.

Time Frame

Baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 < 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas J Wang, MD

Organizational Affiliation

Vanderbilt Univeristy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Franklin Primary Health Center

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36603

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31532959

Citation

Munoz D, Uzoije P, Reynolds C, Miller R, Walkley D, Pappalardo S, Tousey P, Munro H, Gonzales H, Song W, White C, Blot WJ, Wang TJ. Polypill for Cardiovascular Disease Prevention in an Underserved Population. N Engl J Med. 2019 Sep 19;381(12):1114-1123. doi: 10.1056/NEJMoa1815359.

Results Reference

derived

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The SCCS Polypill Pilot Trial

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