Adherence to triple combination therapy in hypertensive patients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51756760

Enrollment

300

Registered

2016-03-03

Start date

2016-03-15

Completion date

Unknown

Last updated

2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Circulatory System Hypertension

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Primary

Measure	Time frame
Difference of percentage of dose taken (PDT) between 1-pill therapy and 2-pill therapy, measured by medication event monitoring system at 12 weeks.	—

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026