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Adherence measured by Medication event monitoring system in TRiple Antihypertensive Combination: single- versus two-pill regimen
Study hypothesis
Triple-component single-pill combination has advantage in adherence over equivalent 2-pill combination therapy.
Ethics approval
Institutional Review Board, Samsung Medical Hospital, Seoul, Republic of Korea, ref: 2015-11-109
Study design
Multi-centre open-label randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Condition
Hypertension
Intervention
Eligible patients are randomized either to the single-pill arm or the two-pill arm, for a total of 12 weeks.
Single-pill arm: SevicarHCT (Olmesartan 20 mg + Amlodipine 5 mg + Hydrochlorothiazide 12.5 mg)
Two-pill arm: Olmetec plus (Olmesartan 20 mg + Hydrochlorothiazide 12.5 mg) and Amlodipine 5 mg
Medications are dispensed in MEMS (MEMS V TrackCap (Aardex, Ltd., Zug, Switzerland), one container for one pill, (thus one container for one-pill group and two containers for two-pill group) and monitored for entire study period and the data is transferred to computer and analyzed by Powerview V (Aardex, Ltd., Zug, Switzerland).
Intervention type
Drug
Phase
Not Applicable
Drug names
1. Olmesartan
2. Amlodipine
3. Hydrochlorothiazide
Primary outcome measure
Difference of percentage of dose taken (PDT) between 1-pill therapy and 2-pill therapy, measured by medication event monitoring system at 12 weeks.
Secondary outcome measures
1. Percentage of days with prescribed dose taken correctly (PDTc) between 1-pill therapy and 2-pill therapy is determined using the medication event monitoring system at 12 weeks
2. Difference in proportion of PDT and PDTc over 80% is measured using the medication event monitoring system at 12 weeks
3. Difference in mean clinic and home systolic blood pressure between 1- and 2-pill therapy is determined at 12 weeks
Overall trial start date
01/02/2016
Overall trial end date
31/12/2018
Background and study aims
Hypertension, also known as high blood pressure, is a very common, long term condition. The heart is responsible for pumping blood around the body to deliver oxygen-rich blood. In order to do this a certain amount of pressure is needed in the blood vessels, but if this pressure is too high, then it puts a great strain on the arteries and heart. Many people with high blood pressure are unaware of it, as it rarely causes any noticeable symptoms. If left untreated however, it dramatically increases the risk of heart disease, kidney disease and stroke, earning it the nickname of the “silent killer”. There are a wide range of medications used to treat high blood pressure, which can be very effective. It has been found however that many patients do not take their medications properly (either by missing doses or taking them sporadically), meaning that they do not receive all of the benefits that their medications are meant to provide. Many blood pressure medications are used in combination with one another and this study will be looking at three: Olmesartan, Amlodipine and Hydrochlorothiazide. The aim of this study is to find out whether patients are more likely to take their combination antihypertensive treatment properly if it is in the form of a single pill or as two pills.
Who can participate?
Adults with hypertension who have been treated with a combination of medications for at least four weeks.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given a single pill to take, which contains Olmesartan 20 mg, Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg, every day for 12 weeks. Those in the second group are given two pills to take every day, one pill containing Olmesartan 20 mg and Hydrochlorothiazide 12.5 mg and the other containing Amlodipine 5 mg, for 12 weeks. Participants in both groups are monitored for the entire 12 week study period in order to find out how well the participants in each group are taking their medication and whether they are taking it correctly. The difference in each groups’ blood pressure is also measured at the clinic and at home, so that the two results can be compared.
Where is the study run from?
Samsung Medical Center (lead centre) and 16 other medical centres in South Korea.
When is the study starting and how long is it expected to run for?
February 2016 to February 2017
Who is funding the study?
Daiichi-Sankyo (Japan)
Who is the main contact?
Dr Jidong Sung
jdsung@skku.edu