Home » Trials » Trial #343 » original TRDS
SLCTR Registration Number
SLCTR/2015/020
Date of Registration
The date of last modification
Mar 01, 2016
View original TRDS
Scientific Title of Trial
TRIUMPH - TRIple Pill vs. Usual care Management for Patients with mild- to - moderate Hypertension
Public Title of Trial
TRIUMPH - TRIple Pill vs. Usual care Management for Patients with mild - to - moderate Hypertension
Disease or Health Condition(s) Studied
Hypertension
Scientific Acronym
TRIUMPH
Public Acronym
TRIUMPH
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
Australian New Zealand Clinical Trials Registry number: ACTRN12612001120864; Clinical Trials Registry – India number: CTRI/2013/02/003388
What is the research question being addressed?
Does early use of a low-dose, triple blood pressure lowering medication improve blood pressure control at 6 months?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy
Assignment
Parallel
Purpose
Treatment
Study Phase
Intervention(s) planned
Study setting : Specialist tertiary care centres Number of arms: Two
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:
strength 1 – Optidoz: Telmisartan 20mg, Amlodipine 2.5mg, HCTZ 6.25mg
strength 2 - Telsartan Trio: Telmisartan 40mg, Amlodipine 5mg, HCTZ 12.5mg
The control group will receive usual blood pressure management provided by the responsible clinician according to current guidelines for a total period of 6 months
Inclusion criteria
Exclusion criteria
On two or more BP lowering drugs
Severe or uncontrolled BP (SBP > 180 mmHg 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 and 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.
Primary outcome(s)
|
1.
Proportion of participants achieving target SBP < 140 mmHg and DBP< 90 mmHG (SBP < 130 mmHg and DBP < 80 mmHg for participants with diabetes and/ or chronic kidney disease) |
[ 6 months ] |
Secondary outcome(s)
|
1.
1.Proportion of participants with BP control at 6 and 12 weeks 2.Mean change in SBP and DBP 3.Tolerance to treatment (using a symptom diary) 4.use of health care services (hospitalizations, medical consultations, tests) 5.self - reported BP lowering medication use (7 day recall) 6.quality of life (using a standardized questionnaire) |
[
|
Target number/sample size
700
Countries of recruitment
Sri Lanka
Anticipated start date
2015-10-01
Anticipated end date
2017-10-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
National Health and Medical Research Council, Australia and Global Alliance for Chronic Disease Implementation Research on Hypertension in Low & Middle Income Countries grant (ID 1040152).
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Prof Senaka Rajapakse
Professor in Medicine & Consultant Physician
Professorial Medical Unit
National Hospital of Sri Lanka
Tel: +94-112 581 835
Mob: +94-777 579 776
senaka@med.cmb.ac.lk, senaka.ucfm@gmail.com
Contact Person for Public Queries
Prof Asita de Silva
Director
Clinical Trials Unit, Faculty of Medicine, University of Kelaniya Thalagolla Road, Ragama, Sri Lanka
Tel: +94 112665266
asitades@gmail.com
Primary study sponsor/organization
The George Institute for Global Health
Level 13, 321 Kent St, Sydney NSW 2000 Australia
Postal Address: PO Box M201, Missenden Rd, NSW 2050 Australia
+61 2 9993 4557
+61 2 9993 4502
rwebster@georgeinstitute.org.au, triumphpm@georgeinstitute.org.in
http://www.georgeinstitute.org.au/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
