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TRIUMPH - TRIple Pill vs. Usual care Management for Patients with mild- to - moderate Hypertension -

SLCTR Registration Number

SLCTR/2015/020


Date of Registration

17 Sep 2015

The date of last modification

Jun 30, 2017


View original TRDS


Trial Status



Application Summary


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 of Health Condition(s) Studied

Hypertension


Scientific Acronym

TRIUMPH


Public Acronym

TRIUMPH


Brief title

None


Universal Trail 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


Trial Details


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


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: Low dose: Telmisartan 20mg, Amlodipine 2.5mg, Chlorthalidone 12.5 mg
Strength 2: High dose: Telmisartan 40mg, Amlodipine 5mg, Chlorthalidone 25 mg

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

  1. Adults 18 or more years of age
  2. Persistent (6 weeks) SBP > 140 mmHg and/or DBP > 90 mmHg (or SBP > 130 mmHg and/or DBP > 80mmHg in patients with diabetes mellitus or chronic kidney disease) despite diet and lifestyle advice and/or the use of single BP lowering drug therapy.
  3. Trial Investigator is unsure as to whether a Triple Pill based therapy or usual care is better.

Exclusion criteria

  1. On two or more BP lowering drugs

  2. Severe or uncontrolled BP (SBP > 180 mmHg and/or DBP > 110 mmHg)

  3. Accelerated hypertension or hypertension at a level where the physician feels that slower up titration of treatment is appropriate (e.g. elderly patients)

  4. Contraindication to any of the components of the Triple Pill

  5. Pregnancy, breast feeding, childbearing potential and not on effective medically accepted method of child birth control.

  6. 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.

  7. Participants with clinically significant abnormal laboratory value judged to be unsuitable for trial participation by the investigator.



Primary outcome(s)

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)


Primary outcome(s) - Time of assessment(s)

6 months


Secondary outcome

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)


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 15 July 2015 (Ref: P/106/05/2015)


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).



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None