Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | polypill versus usual care | 2 months |
| Medication Adherence | polypill-percentage of pills taken, evaluated via pill counts |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas J Wang, MD | Vanderbilt Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin Primary Health Center | Mobile | Alabama | 36603 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31532959 | Derived | 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. |
Not provided
Not provided
Potentially eligible participants were invited to complete a baseline visit. During baseline visit, if eligibility confirmed, patients then randomized in open-label 1:1 fashion to either polypill arm or usual care arm. Only if baseline visit labs yielded an exclusionary result were participants then disqualified from further study participation.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Subjects in this arm will not receive any investigational medications. They will continue to receive usual medical care, as directed by their primary care providers. |
| FG001 | 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. Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Subjects in this arm will not receive any investigational medications. They will continue to receive usual medical care, as directed by their primary care providers. |
| BG001 | Polypill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age was the same for both the Polypill and the Usual care arms. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure | polypill versus usual care | Posted | Mean | Standard Deviation | mm Hg | 12 months |
|
For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Subjects in this arm will not receive any investigational medications. They will continue to receive usual medical care, as directed by their primary care providers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-CV death | Renal and urinary disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas J Wang | UT southwestern | 6159361717 | thomas.wang@UTsouthwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2016 | Jun 25, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D017311 | Amlodipine |
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 months |
| Drug Metabolite Profile | LC/MS/MS-based drug metabolite profile assay screen in the polypill arm. | 12 months |
| LDL Cholesterol | polypill versus usual care | 2 months |
| Insulin Resistance | Measurement of HOMA-IR using fasting glucose and insulin. | Baseline and 12 months |
| 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 |
| Withdrawal by Subject |
|
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.
Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)
| BG002 | Total | Total of all reporting groups |
| Median |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| LDL Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Medication Adherence-Percentage of Pills Taken | polypill arm-evaluation via pill counts. | adherence not assessed in usual care arm; incomplete data for 27 polypill participants, resulting in 101 analyzed of 128 polypill participants who completed 12 month visits | Posted | Median | Inter-Quartile Range | percentage of pills taken | 12 months |
|
|
|
| Primary | LDL Cholesterol | Polypill versus usual care | # of participants in polypill arm analyzed (126) does not match number of polypill participants completed (128; in the participant flow overview) because we were unable to obtain LDL values at baseline for 2 Polypill participants. The lab was unable to calculate and a reflex direct LDL was not processed. | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
| Secondary | Systolic Blood Pressure | polypill versus usual care | The numbers of participants analyzed do not match those of the completed (in the participant flow overview) because this assessment was completed at baseline and 2 months; 291 patients (153 usual care, 138 Polypill) completed 2-month follow-up, whereas 275 (147 Usual Care, 128 Polypill) completed 12-month follow-up. | Posted | Mean | Standard Deviation | mm Hg | 2 months |
|
|
|
| Secondary | Medication Adherence | polypill-percentage of pills taken, evaluated via pill counts | adherence not assessed in usual care arm; incomplete data for 32 polypill participants, resulting in 106 analyzed of 138 polypill participants who completed 2 month visits | Posted | Median | Inter-Quartile Range | percentage of pills taken | 2 months |
|
|
|
| Secondary | Drug Metabolite Profile | LC/MS/MS-based drug metabolite profile assay screen in the polypill arm. | Funding is no longer available to complete the analysis of biomarker measurements. In addition, no future funding is anticipated in order to complete this analysis. | Posted | 12 months |
|
|
| Secondary | LDL Cholesterol | polypill versus usual care | Posted | Mean | Standard Deviation | mg/dL | 2 months |
|
|
|
| Secondary | Insulin Resistance | Measurement of HOMA-IR using fasting glucose and insulin. | Funding is no longer available to complete the analysis of biomarker measurements. In addition, no future funding is anticipated in order to complete this analysis. | Posted | 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. | Funding is no longer available to complete the analysis of biomarker measurements. In addition, no future funding is anticipated in order to complete this analysis. | Posted | Baseline and 12 months |
|
|
| 2 |
| 155 |
| 3 |
| 155 |
| 0 |
| 155 |
| EG001 | 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. Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) | 2 | 148 | 2 | 148 | 0 | 148 |
| non-CV death | Hepatobiliary disorders | Systematic Assessment | alcohol toxicity |
|
| stroke-related death | Vascular disorders | Systematic Assessment |
|
| death from motor vehicle accident | Social circumstances | Systematic Assessment |
|
| Coronary Artery Bypass Surgery | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |