- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02278471
The SCCS Polypill Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36603
- Franklin Primary Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Thomas J Wang, MD, Vanderbilt Univeristy
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Natriuretic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Atorvastatin
- Amlodipine
- Losartan
- Hydrochlorothiazide
Other Study ID Numbers
- 141583
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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