The SCCS Polypill Pilot Trial

NCT02278471 | Completed Phase 2 Results DMC

• 1 other identifier: 141583
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hyperlipidemia

Keywords

combination pill; polypill; primary prevention

Outcome Measures

Primary Outcomes (3)

• Systolic Blood Pressure

  polypill versus usual care

  12 months

• Medication Adherence-Percentage of Pills Taken

  polypill arm-evaluation via pill counts.

  12 months

• LDL Cholesterol

  Polypill versus usual care

  12 months

Secondary Outcomes (6)

• Systolic Blood Pressure

  2 months

• Medication Adherence

  2 months

• Drug Metabolite Profile

  12 months

• LDL Cholesterol

  2 months

• Insulin Resistance

  Baseline and 12 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

Polypill

EXPERIMENTAL

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.

Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)

Interventions

Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) DRUG

Polypill

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Franklin Primary Health Center

Mobile, Alabama, 36603, United States

Location

Related Publications (1)

• 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.

  PMID: 31532959 DERIVED

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

Atorvastatin; Amlodipine; Losartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dihydropyridines; Pyridines; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Thomas J Wang
• Organization: UT southwestern

thomas.wang@UTsouthwestern.edu

6159361717

Study Officials

• Thomas J Wang, MD

  Vanderbilt Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Division of Cardiovascular Medicine

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 30, 2014
• Study Start: December 1, 2015
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: May 14, 2021
• Results First Posted: October 1, 2019

Record last verified: 2021-04

Locations

US (1)