None listed
Conditions
Brief summary
Very low dose multiple combination antihypertensive pharmacotherapy can improve risk/benefit compared to (conventional) moderate dose simple combination therapy because the multiple actions lower blood pressure (BP) more efficiently and the lower doses cause fewer adverse effects. We aim in stable hypertensive patients to carefully quantify and compare blood pressure, tolerability and all adverse effects on 2 different dose very low dose multiple combination antihypertensive regimens, compared to moderate dose simple combination regimen. All patients will receive the 3 treatments, in randomised sequence. All patient file data will be entered into a database by a Research Assistant. All data recorded will be de-identified. All patient data recorded will remain confidential, kept secure in a computer database on a computer locked in the research office. The Principal Investigator will not discuss data collected with the patients during the study. Statistical variance in Polypill treatments like these is not established. This is a pilot trial. The statistical analysis will be undertaken on Excel under the oversight of Professor Hans Stampfer. Should either efficacy or safety appear encouraging, we will seek grant support to extend the study to 3 sites, to recruit sufficient numbers to best establish risk/benefit of the Polypill regimen. A consultation after the study will resolve recommendations for ongoing treatment.
Interventions
Irbesartan 150mg once daily orally
Hydrochlorothiazide 12.5mg once daily orally
9 weeks
Phase A:
Amlodipine 0.5 mg once daily orally
Hydrochlorothiazide 2 mg once daily orally
Spironolactone 2 mg once daily orally
Perindopril 0.75 mg once daily orally
Bisoprolol 0.2 mg once daily orally
for 9 weeks
Phase B:
Amlodipine 1 mg once daily orally
Hydrochlorothiazide 4 mg once daily orally
Spironolactone 4 mg once daily orally
Perindopril 1.5 mg once daily orally
Bisoprolol 0.4 mg once daily orally
Irbesartan 150mg once daily orally Hydrochlorothiazide 12.5mg once daily orally 9 weeks Phase A: Amlodipine 0.5 mg once daily orally Hydrochlorothiazide 2 mg once daily orally Spironolactone 2 mg once daily orally Perindopril 0.75 mg once daily orally Bisoprolol 0.2 mg once daily orally for 9 weeks Phase B: Amlodipine 1 mg once daily orally Hydrochlorothiazide 4 mg once daily orally Spironolactone 4 mg once daily orally Perindopril 1.5 mg once daily orally Bisoprolol 0.4 mg once daily orally each for 9 weeks Patients will be treated in each Phase in randomised order. Tablet counts will be undertaken of returns. No washout is planned, given that the analysed BP and other measurements will not begin until 6 weeks into each phase.
Sponsors
Beyond Community & Health Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
To qualify, patients must have: ECG changes typical of hypertension: T-wave flattening or inversion, and/or voltage LVH and/or left axis deviation. Previous SBP between 150 and 200 mm Hg systolic
Exclusion criteria
No clinical cardiovascular events (angina, acute coronary syndrome/AMI, cardiac failure, TIA or stroke) in the previous 1 year
Outcome results
None listed