HypertensionPhase 2NCT02278471
The SCCS Polypill Pilot Trial
A Phase 2 study testing Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) in people with Hypertension and Hyperlipidemia, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 27 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Primary Health Center
Mobile, Alabama, 36603
About this study
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.
Read the 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.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)
- Keywords
- combination pill, polypill, primary prevention
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
polypill versus usual care
Measured: 12 months
Medication Adherence-Percentage of Pills Taken
polypill arm-evaluation via pill counts.
Measured: 12 months
LDL Cholesterol
Polypill versus usual care
Measured: 12 months
Secondary outcomes (6)
Systolic Blood Pressure
polypill versus usual care
Measured: 2 months
Medication Adherence
polypill-percentage of pills taken, evaluated via pill counts
Measured: 2 months
Drug Metabolite Profile
LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.
Measured: 12 months
LDL Cholesterol
polypill versus usual care
Measured: 2 months
Insulin Resistance
Measurement of HOMA-IR using fasting glucose and insulin.
Measured: 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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startDec 2015
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Wang, Vanderbilt University
- Investigators
- Thomas J Wang, MD, Principal investigator, Vanderbilt Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278471
- Sponsor's protocol ID
- 141583
- Status last verified
- Apr 2021
- First submitted
- 13 Oct 2014
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31532959
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SCCS Polypill Pilot Trial
- ClinicalTrials.gov ID
- NCT02278471
- Acronym / sponsor ID
- 141583
- Conditions
- Hypertension, Hyperlipidemia
- Keywords
- combination pill, polypill, primary prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) | Drug | Polypill |
Primary outcome
Systolic Blood Pressure
Time frame: 12 months
polypill versus usual care
Medication Adherence-Percentage of Pills Taken
Time frame: 12 months
polypill arm-evaluation via pill counts.
LDL Cholesterol
Time frame: 12 months
Polypill versus usual care
6 secondary outcomes
Systolic Blood Pressure
Time frame: 2 months
Medication Adherence
Time frame: 2 months
Drug Metabolite Profile
Time frame: 12 months
LDL Cholesterol
Time frame: 2 months
Insulin Resistance
Time frame: Baseline and 12 months
Inflammatory Profile
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31532959Munoz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Wang, MD principal investigator
Vanderbilt Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) in people with Hypertension and Hyperlipidemia, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.