At a glance
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Prevalence and Incidence of Dyskalemia in Hypertensive Patients Initiating a Fixed Dose Combination Pill of Telmisartan and Amlodipine
In Brief
A Phase 4 clinical trial evaluating Fixed Dose Combination pill of Telmisartan 40mg and Amlodipine 5 mg for Hypertension and Potassium Imbalance. Completed, enrolled 1,090 participants across 1 site.
Detailed Summary
Hypertension is a major public health issue associated with significant morbidities and mortality. Fixed-dose combination (FDC) pills, combining 2 or more classes of antihypertensive medications have considerable appeal because these drugs may reduce blood pressure more effectively and efficiently compared to monotherapy. However, because FDC medication causes 'dyskalemia', the occurrence of either hypo- or hyper-kalemia, which requires laboratory testing, implementing FDC is hampered in some low- and middle-income countries where laboratory testing is limited. This study will be conducted in the area of Mirpur in Dhaka, Bangladesh, to 1) estimate the prevalence of dyskalemia in hypertensive patients who are candidates for pharmacotherapy; and 2) of those patients initiating a FDC combining telmisartan 40 mg/amlodipine 5 mg, estimate the incidence of dyskalemia at two months later. Telmisartan is a widely prescribed drug approved by the Directorate General of Drug Administration (DGDA). If the prevalence and incidence of dyskalemia is low, as anticipated, this study results will provide evidence that routine laboratory testing might not be necessary. It is to be mentioned that Telmisartan is not a new drug and it is a widely prescribed drug approved by the Directorate General of Drug Administration (DGDA), Bangladesh
Study Details
Timeline
Interventions
Participants without prevalent hyperkalemia will receive the fixed-dose combination pill of Telmisartan and Amlodipine, once daily for 3 months.