None listed
Conditions
Brief summary
This is a randomised, parallel, open-label study for patients with hypertension, conducted by George Medicines. Ethical approval has been sought in November 2017, shortly followed by regulatory acknowledgement. This research project aims to understand whether a single pill containing 3 types of blood pressure lowering medications at quarter-standard doses will more effectively lower blood pressure and have fewer side effects compared to a standard dose of a single type of hypertensive medication. This research project will assess two different pill combinations for the treatment of high blood pressure, they are: • Ultra-low dose: telmisartan (10 mg), amlodipine (1.25 mg), and indapamide (0.625 mg) • Low-dose: losartan (25 mg), amlodipine (2.5 mg), and hydrochlorothiazide (12.5 mg)
Interventions
Arm 1
Ultra-low dose TEL/AML/IND: telmisartan (TEL 10 mg once daily, oral tablet), amlodipine (AML 1.25 mg once daily, oral tablet), and indapamide (IND 0.625 mg once daily oral tablet) for two weeks
Or
Arm 2
Standard-low -dose LOS/AML/HCT: losartan (LOS 25 mg once daily, oral tablet), amlodipine (AML 2.5 mg once daily, oral tablet), and hydrochlorothiazide (HCT 12.5 mg once daily, oral tablet) for four weeks.
Each drug will be administered via oral capsule once daily. Adherence will be monitor
Arm 1 Ultra-low dose TEL/AML/IND: telmisartan (TEL 10 mg once daily, oral tablet), amlodipine (AML 1.25 mg once daily, oral tablet), and indapamide (IND 0.625 mg once daily oral tablet) for two weeks Or Arm 2 Standard-low -dose LOS/AML/HCT: losartan (LOS 25 mg once daily, oral tablet), amlodipine (AML 2.5 mg once daily, oral tablet), and hydrochlorothiazide (HCT 12.5 mg once daily, oral tablet) for four weeks. Each drug will be administered via oral capsule once daily. Adherence will be monitored by drug tablet return and diary card completion.
Sponsors
George Medicines
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide written, informed consent; 2. Be male or female aged 18 years or over; 3. Have hypertension, defined as an in-office systolic blood pressure of more than 140 mm Hg and/or a diastolic blood pressure of more than 90 mmHg taken in triplicate, supine, after 5 minutes rest, taken over a 10-minute period. Patients may be untreated, newly diagnoses, or have previously been treated with an antihypertensive (but must have a two-week washout period from previous treatments); 4. Not be of childbearing potential, or agree to use contraception for the duration of the protocol (e.g. diaphragm, male condom, combined oral contraceptive pill, copper intrauterine device, levonorgestrel intrauterine system or etonogestrel implant). Note the partners of male participants must also use contraception for the duration of the protocol; and 5. Willing to comply with all study assessment and attend all visits.
Exclusion criteria
1. Have severe hypertension, defined as an in-office systolic blood pressure more than 180 mm Hg and/or a diastolic blood pressure more than 110 mm Hg on three consecutive measurements taken over a 10-minute period; 2. Have hypertension with a known secondary cause (e.g. primary aldosteronism); 3. Have a previously recorded intolerance to any angiotensin receptor blocker, calcium channel blocker, diuretic or sulphonamide; 4. Have received antihypertensive treatment within the last two weeks; 5. Have concomitant illness, physical impairment or mental condition which in the opinion of the Investigator could interfere with the conduct of the study including assessments 6. Have unstable cardiac disease; 7. Have severe kidney disease; 8. Have severe liver disease; 9. Be pregnant or breastfeeding; 10. Any other medical condition that the Investigator believes should preclude the patient’s participation in the study; 11. Have participates in another clinical trial within 30 days of dosing; or 12. Have inability or unwillingness to provide written informed consent.
Outcome results
None listed