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Trial registered on ANZCTR


Trial ID
ACTRN12612001120864
Ethics application status
Approved
Date submitted
18/10/2012
Date registered
19/10/2012
Date last updated
25/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
TRIUMPH - TRIple Pill vs. Usual care Management for Patients with mild-to-moderate Hypertension
Scientific title
Randomised controlled trial of early use of a simplified treatment regimen incorporating a half-dose, three-in-one blood pressure lowering pill vs. usual care for improving hypertension control
Secondary ID [1] 281410 0
None
Universal Trial Number (UTN)
Trial acronym
TRIUMPH - TRIple Pill vs. Usual care Management for Patients with mild-to-moderate Hypertension
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild to moderate hypertension 287657 0
Condition category
Condition code
Cardiovascular 287995 287995 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention arm will start on the lower dose of the drug under investigation with the option to move to the higher dose if blood pressure is not controlled to the responsible clinician's satisfaction. Each dose version is taken as one tablet once a day for a total period of 6 months.
Components of each dose version are as follows:
Low Dose: Telmisartan 20mg, Amlodipine 2.5mg, Chlorthalidone 12.5mg
High Dose: Telmisartan 40mg, Amlodipine 5mg, Chlorthalidone 25mg
Intervention code [1] 285900 0
Treatment: Drugs
Comparator / control treatment
Usual blood pressure management provided by the responsible clinician according to current guidelines for a total period of 6 months
Control group
Active

Outcomes
Primary outcome [1] 288203 0
Proportion of patients achieving target blood pressure (BP) at the end of 6 months follow-up: systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg (SBP < 130 mmHg and DBP < 85 mmHg for patients with diabetes and chronic kidney disease).
BP will be measured using automated BP machines (Omron) during the trial visit using standardised BP measurement protocols (e.g. sitting, 2 measurements taken 5 minutes apart)
Timepoint [1] 288203 0
6 months
Secondary outcome [1] 299597 0
Proportion of patients reaching target BP: SBP < 140 mmHg and DBP < 90 mmHg (SBP < 130 mmHg and DBP < 85 mmHg for patients with diabetes and chronic kidney disease).
BP will be measured using automated BP machines (Omron) during the trial visit using standardised BP measurement protocols (e.g. sitting, 2 measurements taken 5 minutes apart)
Timepoint [1] 299597 0
6 weeks, 12 weeks
Secondary outcome [2] 299598 0
Mean change in SBP and DBP
BP will be measured using automated BP machines (Omron) during the trial visit using standardised BP measurement protocols (e.g. sitting, 2 measurements taken 5 minutes apart)
Timepoint [2] 299598 0
6 months
Secondary outcome [3] 299599 0
Tolerance to treatment will be assessed by comparing the rates of medication discontinuation, due to side effects, in both arms of the trial.
No increased side effects are expected beyond those expected for the individual medications taken either as components of the Triple Pill or the individual medications taken in the usual care arm. Cessation of medication due to side effects will be assessed by asking the patient why (if relevant) they have stopped taking their medication.
Timepoint [3] 299599 0
6 months
Secondary outcome [4] 299600 0
Use of health care services (hospitalisations, medical consultations, tests).
Use of such services will be assessed by patient recall of relevant health service utilisation during the trial period. This data will be collected by the study nurse during the trial visit.
Timepoint [4] 299600 0
6 months
Secondary outcome [5] 299601 0
Self-reported BP lowering medication use (7-day recall) - adherence defined as taking the drug for at least 4 out of the previous 7 days.
Medication use will be ascertained during the study visit by patient recall of how many times they took their medication over the last 7 days.
Timepoint [5] 299601 0
6 months
Secondary outcome [6] 299602 0
Quality of life will be assessed using the EQ5D health assessment questionnaire.
Timepoint [6] 299602 0
6 months

Eligibility
Key inclusion criteria
* The investigator is satisfied that the patient has persistent hypertension (SBP>140mmHg and/or DBP>90mmHg; or SBP>130mmHg and/or DBP>80mmHg in patients with diabetes mellitus or chronic kidney disease) requiring initiation of pharmacological treatment (in patients not taking drug therapy) or up-titration of pharmacological treatment (in patients taking single drug therapy)

*Trial Investigator is unsure as to whether a Triple Pill based therapy or usual care is better.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*on 2 or more BP lowering drugs
* severe or uncontrolled hypertension (SBP > 180mmHg and/or DBP > 110 mmHg)
*Accelerated hypertension or hypertension at a level where the physician feels that slower up-titration of treatment is appropriate (e.g. elderly patients)
*Contraindication to any of the components of the Triple Pill
*Pregnancy, breast feeding, childbearing potential not on effective medically accepted method of child birth control.
*Unstable medical condition or known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation, dialysis.
*Participants with clinically significant abnormal laboratory value judged to be unsuitable for trial participation by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be conducted through a central, computer-based randomisation service built into the electronic Case Record Form
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation built into the eCRF stratified by study centre and prescription of BP lowering therapy at baseline.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Pre-specified subgroup analyses will be conducted on groups defined by treatment at baseline i.e. either treatment naive or uncontrolled monotherapy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7513 0
Sri Lanka
State/province [1] 7513 0
Colombo

Funding & Sponsors
Funding source category [1] 286173 0
Government body
Name [1] 286173 0
NHMRC
Address [1] 286173 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 286173 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 3, 50 Bridge St
Sydney NSW 2000
Australia
Country
Australia
Secondary sponsor category [1] 284984 0
None
Name [1] 284984 0
Address [1] 284984 0
Country [1] 284984 0
Other collaborator category [1] 278771 0
Other Collaborative groups
Name [1] 278771 0
RemediumOne
Address [1] 278771 0
No 41/10, Guildford Crescent, Colombo 07, Sri Lanka
Country [1] 278771 0
Sri Lanka

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288239 0
University of Kelaniya Ethics Review Committee
Ethics committee address [1] 288239 0
Ethics committee country [1] 288239 0
Date submitted for ethics approval [1] 288239 0
31/10/2012
Approval date [1] 288239 0
14/12/2015
Ethics approval number [1] 288239 0
Ethics committee name [2] 294150 0
Royal Prince Alfred Hospital Ethics Review Committee
Ethics committee address [2] 294150 0
Royal Prince Alfred Hospital, Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [2] 294150 0
Australia
Date submitted for ethics approval [2] 294150 0
25/11/2015
Approval date [2] 294150 0
31/12/2015
Ethics approval number [2] 294150 0
HREC/14/RPAH/52

Summary
Brief summary
The study is a prospective, open, randomised controlled clinical trial (n=700) of a combination blood pressure lowering pill (“Triple Pill”)-based strategy compared to usual care among individuals with newly diagnosed hypertension on no or minimal drug therapy, augmented by a cost-effectiveness analysis and a formal process evaluation.
The key hypothesis tested is that there is no difference in the proportion of patients reaching their target blood pressure at 6 months compared to usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34847 0
Prof Anushka Patel
Address 34847 0
The George Institute for Global Health, Level 5, 1 King St, Newtown NSW 2042
Country 34847 0
Australia
Phone 34847 0
+ 61 2 8052 4439
Fax 34847 0
Email 34847 0
apatel@georgeinstitute.org.au
Contact person for public queries
Name 18094 0
Dr Ruth Webster
Address 18094 0
PO Box M201
Missenden Rd
Camperdown NSW 2050
Country 18094 0
Australia
Phone 18094 0
+61 2 8052 4557
Fax 18094 0
+61 2 8052 4502
Email 18094 0
rwebster@georgeinstitute.org.au
Contact person for scientific queries
Name 9022 0
Dr Ruth Webster
Address 9022 0
PO Box M201
Missenden Rd,
Camperdown NSW 2050
Country 9022 0
Australia
Phone 9022 0
+61 2 8052 4557
Fax 9022 0
+61 2 8052 4502
Email 9022 0
rwebster@georgeinstitute.org.au