Adherence to triple combination therapy in hypertensive patients
| ISRCTN | ISRCTN51756760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51756760 |
| Secondary identifying numbers | 20151026 |
- Submission date
- 01/03/2016
- Registration date
- 03/03/2016
- Last edited
- 25/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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.
What are the possible benefits and risks of participating?
Not provided at time of registration.
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
Contact information
Scientific
Division of Cardiology
Department of Medicine
SungKyunkwan University School of Medicine
81 Ilwon-ro, Kangnam-gu
Seoul
06351
Korea, South
| Phone | +82 2 3410 3419 |
|---|---|
| jdsung@skku.edu |
Study information
| Study design | Multi-centre open-label randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Adherence measured by Medication event monitoring system in TPiple Antihypertensive Combination: single- versus two-pill regimen |
| Study acronym | AMTRAC |
| Study objectives | Triple-component single-pill combination has advantage in adherence over equivalent 2-pill combination therapy. |
| Ethics approval(s) | Institutional Review Board, Samsung Medical Hospital, Seoul, Republic of Korea, ref: 2015-11-109 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2016 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 145 |
| Key inclusion criteria | 1. Hypertensive patients whose clinic BP (defined below) is systolic > 140 mmHg or diastolic > 90 mmHg, and has been on dual-component therapy for at least 4 weeks with one of the following combination either in SPC or free-equivalent combination in a dose equivalent dose to olmesartan 20 mg or amlodipine 5 mg or hydrochlorothiazide 12.5 mg/day: 1.1. Angiotensin receptor blocker(ARB) + Calcium channel blocker(CCB) 1.2. ARB + thiazide diuretics 1.3. CCB + thiazide diuretics 2. Patients who provide informed consent to join the study 3. Aged 18 years or over |
| Key exclusion criteria | 1. Severe HTN (baseline clinic SBP > 180 mmHg or DBP > 110 mmHg) 2. Suspicious of secondary HTN or any other severe target organ damage or hypertensive emergency necessitating urgent BP control 3. Past history of intolerance or existing contraindication to either CCB or ARB or thiazide diuretics 4. Medical conditions which are likely to result in regimen change such as recent (within 6 months) major cardiovascular events. 5. Cases with severe comorbidities which is considered to be inappropriate for enrollment by investigators, including (but not confined to) severe hepatic or renal insufficiency, dementia with significant problem in keeping regular medication, etc. 6. Pregnancy or planned pregnancy |
| Date of first enrolment | 15/03/2016 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- Korea, South
Study participating centres
Seoul
06351
Korea, South
Seoul
03181
Korea, South
Chuncheon-si
24289
Korea, South
Busan
49267
Korea, South
Incheon
22711
Korea, South
Goyang-si
10408
Korea, South
Cheonan-si
31116
Korea, South
Seoul
02500
Korea, South
Bucheon-si
14754
Korea, South
Goyang-si
10380
Korea, South
Busan
48108
Korea, South
Seoul
06973
Korea, South
Changwon-si
51353
Korea, South
Daejeon
35015
Korea, South
Seoul
01450
Korea, South
Daejeon
35233
Korea, South
Seoul
05368
Korea, South
Sponsor information
University/education
81 Ilwon-ro, Kangnam-gu
Seoul
06351
Korea, South
"ROR" |
https://ror.org/04q78tk20 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Daiichi Sankyo Company, Limited, Daiichi Sankyo Co., Ltd.
- Location
- Japan
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 02/03/2020 | 02/03/2020 | No | No | |
| Results article | 13/02/2021 | 25/04/2023 | Yes | No |
Additional files
- ISRCTN51756760_BasicResults_02Mar20.pdf
- uploaded 02/03/2020
Editorial Notes
25/04/2023: Publication reference and total final enrolment added.
02/03/2020: The basic results of this trial have been uploaded as an additional file.
19/03/2018: The following changes have been made:
1.The recruitment end date has been changed from 01/08/2016 to 31/08/2018.
2. The intention to publish date has been changed from 01/02/2018 to 31/12/2019.
15/03/2018: The overall trial end date has been changed from 01/02/2017 to 31/12/2018.
12/10/2017: internal review.
