Trial Outcomes & Findings for The SCCS Polypill Pilot Trial (NCT NCT02278471)
NCT ID: NCT02278471
Last Updated: 2021-05-14
Results Overview
polypill versus usual care
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
303 participants
Primary outcome timeframe
12 months
Results posted on
2021-05-14
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
148
|
|
Overall Study
COMPLETED
|
147
|
128
|
|
Overall Study
NOT COMPLETED
|
8
|
20
|
Reasons for withdrawal
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
15
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
The SCCS Polypill Pilot Trial
Baseline characteristics by cohort
| Measure |
Usual Care
n=155 Participants
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.
|
Polypill
n=148 Participants
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)
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 6 • n=99 Participants
|
56 years
STANDARD_DEVIATION 6 • n=107 Participants
|
56 years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
151 Participants
n=99 Participants
|
141 Participants
n=107 Participants
|
292 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=99 Participants
|
148 participants
n=107 Participants
|
303 participants
n=206 Participants
|
|
Systolic Blood Pressure
|
140 mm Hg
STANDARD_DEVIATION 17 • n=99 Participants
|
140 mm Hg
STANDARD_DEVIATION 18 • n=107 Participants
|
140 mm Hg
STANDARD_DEVIATION 17 • n=206 Participants
|
|
LDL Cholesterol
|
112 mg/dL
STANDARD_DEVIATION 37 • n=99 Participants
|
114 mg/dL
STANDARD_DEVIATION 32 • n=107 Participants
|
113 mg/dL
STANDARD_DEVIATION 34 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthspolypill versus usual care
Outcome measures
| Measure |
Usual Care
n=147 Participants
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.
|
Polypill
n=128 Participants
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)
|
|---|---|---|
|
Systolic Blood Pressure
|
138 mm Hg
Standard Deviation 23
|
131 mm Hg
Standard Deviation 21
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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
polypill arm-evaluation via pill counts.
Outcome measures
| Measure |
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.
|
Polypill
n=101 Participants
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)
|
|---|---|---|
|
Medication Adherence-Percentage of Pills Taken
|
—
|
86 percentage of pills taken
Interval 79.0 to 93.0
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: \# 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.
Polypill versus usual care
Outcome measures
| Measure |
Usual Care
n=147 Participants
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.
|
Polypill
n=126 Participants
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)
|
|---|---|---|
|
LDL Cholesterol
|
109 mg/dL
Standard Deviation 32
|
98 mg/dL
Standard Deviation 35
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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.
polypill versus usual care
Outcome measures
| Measure |
Usual Care
n=153 Participants
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.
|
Polypill
n=138 Participants
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)
|
|---|---|---|
|
Systolic Blood Pressure
|
133 mm Hg
Standard Deviation 19
|
128 mm Hg
Standard Deviation 19
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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
polypill-percentage of pills taken, evaluated via pill counts
Outcome measures
| Measure |
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.
|
Polypill
n=106 Participants
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)
|
|---|---|---|
|
Medication Adherence
|
—
|
98 percentage of pills taken
Interval 91.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthspolypill versus usual care
Outcome measures
| Measure |
Usual Care
n=153 Participants
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.
|
Polypill
n=137 Participants
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)
|
|---|---|---|
|
LDL Cholesterol
|
108 mg/dL
Standard Deviation 35
|
90 mg/dL
Standard Deviation 33
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
Measurement of HOMA-IR using fasting glucose and insulin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
Plasma levels of IL-17, IFN-g, IL-6, IL-10, high sensitivity C-reactive protein, TNFa, IL-4.
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 3 serious events
Other events: 0 other events
Deaths: 2 deaths
Polypill
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Usual Care
n=155 participants at risk
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.
|
Polypill
n=148 participants at risk
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)
|
|---|---|---|
|
Renal and urinary disorders
non-CV death
|
0.00%
0/155 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
0.68%
1/148 • Number of events 1 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
|
Hepatobiliary disorders
non-CV death
|
0.00%
0/155 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
0.68%
1/148 • Number of events 1 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
|
Vascular disorders
stroke-related death
|
0.65%
1/155 • Number of events 1 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
0.00%
0/148 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
|
Social circumstances
death from motor vehicle accident
|
0.65%
1/155 • Number of events 1 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
0.00%
0/148 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
|
Cardiac disorders
Coronary Artery Bypass Surgery
|
0.65%
1/155 • Number of events 1 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
0.00%
0/148 • For the duration of the study period (Dec 2015 through June 2018) and for each participant's 12-month period of participation
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place