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Trial registered on ANZCTR
Registration number
ACTRN12618001625268
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
3/10/2018
Date last updated
3/10/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Tolerability of different doses of blood pressure lowering Polypill
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Scientific title
Tolerability and blood pressure lowering of two different dose antihypertensive Polypills, compared to conventional dual combination
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Secondary ID [1]
295393
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Nil
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Universal Trial Number (UTN)
U1111-1216-5921
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Trial acronym
PDS (Polypill Dose Study)
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Linked study record
Nil
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Health condition
Health condition(s) or problem(s) studied:
Systemic hypertension
308623
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Complicated hypertension
308624
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Condition category
Condition code
Cardiovascular
307570
307570
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
301706
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Prevention
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Comparator / control treatment
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.
The comparator/reference treatment will be the Irbesartan 150mg + Hydrochlorothiazide 12.5mg once daily Phase
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Control group
Active
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Outcomes
Primary outcome [1]
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Adverse events
eg faintness, syncope, rash, nausea
Any intolerance and all specific adverse symptoms will be evaluated every 3 weeks, in the clinic and by telephone.
All new or increased symptoms will be documented and evaluated as possible adverse events.
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Assessment method [1]
306550
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Timepoint [1]
306550
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3 Phases, each of 9 weeks duration
Baseline (commencement of Phase 1 of drug treatment)
9 weeks post-commencement = beginning of Phase 2
18 weeks = beginning of Phase 3
Finish at 27 weeks
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Secondary outcome [1]
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Mean blood pressure (clinic, ambulatory)
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Assessment method [1]
348847
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Timepoint [1]
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At baseline and at 6 & 9 weeks in each of the 3 Phases, clinic and 24 hour ambulatory BP & HR
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Secondary outcome [2]
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Mean heart rate (ECG, clinic, ambulatory)
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Assessment method [2]
352253
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Timepoint [2]
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At baseline and at 6 & 9 weeks in each of the 3 Phases, ECG, clinic and 24 hour ambulatory HR
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No clinical cardiovascular events (angina, acute coronary syndrome/AMI, cardiac failure, TIA or stroke) in the previous 1 year
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Sealed Polypill capsule
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation, using this website/link:
http://numbergenerator.org/20randomnumbers#!numbers=20&low=1&high=6&unique=true&start=false
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
t-test
ANOVA
As this is our first study with different doses of Polypill, the variance and comparability in our patients is unknown. A previous similar study which used placebo as a comparator recruited 20 participants. (Chow CK, Thakar J, Bennett A, et al. Quarter-dose quadruple combination therapy for initial treatment of hypertension: placebo-controlled, crossover, randomised trial and systematic review. Lancet 2017;389:1035-42.)
An interim analysis will be undertaken and if findings are unconvincing, recruitment will be continued.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2018
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Actual
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Date of last participant enrolment
Anticipated
31/10/2019
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Actual
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Date of last data collection
Anticipated
6/05/2020
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Beyond Community & Health Foundation
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Address [1]
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Beyond Community & Health Foundation
2/62 Archibald St
Willagee WA 6156
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Country [1]
299984
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Beyond Community & Health Foundation
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Address
Beyond Community & Health Foundation
2/62 Archibald St
Willagee WA 6156
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Country
Australia
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Secondary sponsor category [1]
299365
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University
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Name [1]
299365
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University of Western Australia
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Address [1]
299365
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35 Stirling Hwy
Crawley WA 6009
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Country [1]
299365
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Australia
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Other collaborator category [1]
280216
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Individual
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Name [1]
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Professor Jennifer H Martin
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Address [1]
280216
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School of Medicine & Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
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Country [1]
280216
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Australia
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Other collaborator category [2]
280369
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Individual
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Name [2]
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Professor Hans Stampfer
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Address [2]
280369
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School of Psychiatry and Clinical Neurosciences
University of Western Australia
35 Stirling Hwy
Nedlands WA 6009
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Country [2]
280369
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300840
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St John of God Health Care HREC
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Ethics committee address [1]
300840
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St John of God Health Care, Salvado Rd, Subiaco WA 6008
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Ethics committee country [1]
300840
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Australia
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Date submitted for ethics approval [1]
300840
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06/12/2017
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Approval date [1]
300840
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13/12/2017
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Ethics approval number [1]
300840
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Ref 1077
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Summary
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.
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Trial website
Nil
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Trial related presentations / publications
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Public notes
Basis and discussion for the low dosing used in the current study:
Dimmitt S, Stampfer H, Martin JH.
When less is more – efficacy with less toxicity at the ED50.
British J Clin Pharmacol 2017 83: 1365-8.
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Contacts
Principal investigator
Name
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Prof Simon B Dimmitt
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Address
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Beyond Community & Health Foundation
2/62 Archibald St
Willagee WA 6156
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Country
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Australia
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Phone
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+61419042914
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Fax
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+618 9331 7299
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Simon B Dimmitt
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Address
84991
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Beyond Community & Health Foundation
2/62 Archibald St
Willagee WA 6156
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Country
84991
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Australia
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Phone
84991
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+618 9331 7233
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Fax
84991
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+618 9331 7299
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Email
84991
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[email protected]
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Contact person for scientific queries
Name
84992
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Prof Simon B Dimmitt
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Address
84992
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Beyond Community & Health Foundation
2/62 Archibald St
Willagee WA 6156
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Country
84992
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Australia
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Phone
84992
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+618 9331 7233
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Fax
84992
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+618 9331 7299
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Email
84992
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23662
Study protocol
23663
Clinical study report
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF