Condition category
Circulatory System
Date applied
01/03/2016
Date assigned
03/03/2016
Last edited
01/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jidong Sung

ORCID ID

Contact details

Division of Cardiology
Department of Medicine
SungKyunkwan University School of Medicine
81 Ilwon-ro
Kangnam-gu
Seoul
06351
Korea
South
+82 2 3410 3419
jdsung@skku.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20151026

Study information

Scientific title

Adherence measured by Medication event monitoring system in TPiple Antihypertensive Combination: single- versus two-pill regimen

Acronym

AMTRAC

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

Trial type

Treatment

Patient information sheet

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 measures

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

01/02/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

15/03/2016

Recruitment end date

01/08/2016

Locations

Countries of recruitment

Korea, South

Trial participating centre

Samsung Medical Center
81, Irwon-ro, Gangnam-gu
Seoul
06351
Korea, South

Trial participating centre

Kangbuk Samsung Hospital
29, Saemunan-ro, Jongno-gu
Seoul
03181
Korea, South

Trial participating centre

Kangwon National University Hospital
156, Baengnyeong-ro
Chuncheon-si
24289
Korea, South

Trial participating centre

Kosin University Gospel Hospital
262, Gamcheon-ro, Seo-gu
Busan
49267
Korea, South

Trial participating centre

Catholic Kwandong University International St. Mary's Hospital
25, Simgok-ro 100beon-gil, Seo-gu
Incheon
22711
Korea, South

Trial participating centre

National Cancer Center
323, Ilsan-ro, Ilsandong-gu
Goyang-si
10408
Korea, South

Trial participating centre

Dankook University Hospital
201, Manghyang-ro, Dongnam-gu
Cheonan-si
31116
Korea, South

Trial participating centre

Samyook Medical Center
82, Mangu-ro, Dongdaemun-gu
Seoul
02500
Korea, South

Trial participating centre

Sejong Hospital
28, Hohyeon-ro 489beon-gil, Sosa-gu
Bucheon-si
14754
Korea, South

Trial participating centre

Inje University Ilsan Paik Hospital
170, Juhwa-ro, Ilsanseo-gu
Goyang-si
10380
Korea, South

Trial participating centre

Inje University Haeundae Paik Hospital
875, Haeun-daero, Haeundae-gu
Busan
48108
Korea, South

Trial participating centre

Chung-Ang University Hospital
102, Heukseok-ro, Dongjak-gu
Seoul
06973
Korea, South

Trial participating centre

Samsung Changwon Hospital
158, Paryong-ro, MasanHoewon-gu
Changwon-si
51353
Korea, South

Trial participating centre

Chungnam National University Hospital
282, Munhwa-ro, Jung-gu
Daejeon
35015
Korea, South

Trial participating centre

Kepco Medical Center
308, Uicheon-ro, Dobong-gu
Seoul
01450
Korea, South

Trial participating centre

Eulji University Hospital
95, Dunsanseo-ro, Seo-gu
Daejeon
35233
Korea, South

Trial participating centre

VHS Medical Center
53, Jinhwangdo-ro 61-gil, Gangdong-gu
Seoul
05368
Korea, South

Sponsor information

Organisation

Sungkyunkwan University School of Medicine

Sponsor details

81 Ilwon-ro
Kangnam-gu
Seoul
06351
Korea
South

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Daiichi-Sankyo

Alternative name(s)

Daiichi Sankyo Company, Limited

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Japan

Results and Publications

Publication and dissemination plan

Not provided at time of registration.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes