Operational Lessons Learned from Successfully Managing a Clinical Trial on Hypertension Management

High blood pressure (BP) is the leading cause of preventable morbidity and mortality globally. The benefits of BP lowering in reducing cardiovascular (CV) events are well established and there is clear evidence that greater BP lowering confers a greater reduction in CV events 1–3.

Unfortunately, however, despite the availability of safe, well-tolerated, and relatively in-expensive BP-lowering therapies, <14% of adults with hypertension have BP controlled to a systolic/diastolic BP <140/90 mmHg 4. The COBRA-BPS study highlighted the magnitude of uncontrolled hypertension in rural Sri Lanka, with approximately 64% having uncontrolled BP 5.

Combination therapy has the potential to address the aforementioned barrier of under treatment of hypertension with monotherapy as well as physician inertia 6.

RemediumOne is currently managing the Sri Lankan component of a multi-country trial that is evaluating the safety and efficacy of a unique, three-in-one pill for treatment of hypertension. With 8 participating countries, Sri Lanka has contributed to over 40% of global recruitment. Here are the key operational lessons learned from the successful progress of this trial.

To explore how RemediumOne can enhance participant engagement and enrollment for clinical trials, get in touch with our Leadership Team or peruse our capabilities in further detail.

Contributors: Anuradha Dahanayaka (Senior Manager- Clinical Operations), Gayan Wijeratne (Project Lead), Zulaiha Liyakath (CRA).

GMRx2 - Lessons learned
Operational Lessons Learned from Successfully Managing a Clinical Trial on Hypertension Management

1. Xie X, Atkins E, Lv J, et al. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: Updated systematic review and meta-analysis. The Lancet. 2016;387(10017). doi:10.1016/S0140-6736(15)00805-3

Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: Meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ (Online). 2009;338(7705). doi:10.1136/bmj.b1665

Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: A systematic review and meta-analysis. The Lancet. 2016;387(10022). doi:10.1016/S0140-6736(15)01225-8

Al-Makki A, DiPette D, Whelton PK, et al. Hypertension pharmacological treatment in adults: A world health organization guideline executive summary. Hypertension. 2022;79(1). doi:10.1161/HYPERTENSIONAHA.121.18192

Jafar TH, Gandhi M, Jehan I, et al. Determinants of Uncontrolled Hypertension in Rural Communities in South Asia-Bangladesh, Pakistan, and Sri Lanka. Am J Hypertens. 2018;31(11). doi:10.1093/ajh/hpy071

Okonofua EC, Simpson KN, Jesri A, Rehman SU, Durkalski VL, Egan BM. Therapeutic inertia is an impediment to achieving the Healthy People 2010 blood pressure control goals. Hypertension. 2006;47(3). doi:10.1161/01.HYP.0000200702.76436.4b

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