“RemediumOne played a pivotal role in the success of the TRIUMPH trial in Sri Lanka. As the trial management organization entrusted with overseeing the trial operations, RemediumOne executed all activities required for a successful clinical trial at an optimal level, exceeding client expectations. Their expertise and meticulous approach ensured seamless coordination of various trial components, including participant recruitment, data collection, monitoring, and adherence to protocol. RemediumOne’s dedication to maintaining the highest standards in trial management contributed significantly to the overall success of the TRIUMPH trial in Sri Lanka. Their commitment to excellence and unwavering focus on quality were instrumental in achieving accurate and reliable trial results, ultimately advancing hypertension management research for the benefit of patients worldwide.”
TRIUMPH – TRIple Pill vs. Usual care Management for Patients with mild-to-moderate Hypertension
Overview: The TRIUMPH (TRIple Pill vs. Usual care Management for Patients with mild-to-moderate Hypertension) trial is a landmark randomized controlled trial that compared the effectiveness of the TRIple Pill regimen with usual care management in patients with mild-to-moderate hypertension. Sri Lanka made a significant contribution to the TRIUMPH trial, showcasing the country’s dedication and expertise in hypertension management research.
Study Design:
- The TRIUMPH trial was a multicenter, open label, randomized controlled trial conducted in multiple countries, including Sri Lanka.
- Participants were randomly assigned to either the intervention group receiving the TRIple Pill regimen or the control group receiving usual care management.
- The primary outcome measure was the change in blood pressure from baseline to 6 months.
Intervention Group:
- Participants in the intervention group received the TRIple Pill regimen, which consisted of a single fixed-dose combination tablet containing three antihypertensive drugs: amlodipine, telmisartan, and chlorthalidone.
- The TRIple Pill was administered once daily, making it a convenient and simplified treatment option.
Control Group:
- Participants in the control group received usual care management, which involved the prescription of antihypertensive medications according to local guidelines and the discretion of the treating physicians.
Key Findings:
- The TRIUMPH trial demonstrated that the TRIple Pill regimen led to a significantly greater reduction in blood pressure compared to usual care management.
- At 6 months, the intervention group achieved a mean reduction in systolic blood pressure of 8.7 mmHg more than the control group.
- The intervention group also showed a higher rate of achieving blood pressure control (defined as <140/90 mmHg) compared to the control group.
- Adherence to the TRIple Pill regimen was high among participants, highlighting its feasibility and acceptability.
Safety and Adverse Events:
- The TRIple Pill regimen was well-tolerated by participants, with a low incidence of adverse events.
- The most commonly reported adverse events were mild and transient, such as dizziness and fatigue, and occurred at similar rates in both groups.
Conclusion:
- The TRIUMPH trial, with the valuable contribution from Sri Lanka, demonstrated that the TRIple Pill regimen is an effective and well-tolerated treatment option for patients with mild-to-moderate hypertension.
- The simplified approach of combining three antihypertensive drugs into a single pill resulted in significant blood pressure reduction and improved blood pressure control rates.
- Sri Lanka’s involvement in the TRIUMPH trial underscores the country’s commitment to advancing hypertension management research and improving patient outcomes.
Please note that the provided summary is based on the information available in the publication. It is always recommended to refer to the original publication for detailed information and a complete understanding of the study.