The SCCS Polypill Pilot Trial

Hypertension Clinical Trial

Official title:

The SCCS Polypill Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278471
• Other study ID #: 141583
• Status: Completed
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: June 27, 2018

Study information

• Verified date: April 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: June 27, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Franklin Primary Health Center	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

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