Occurrence of Dyskalemia With Treatment for Hypertension (OK)

NCT05155436 PHASE4 COMPLETED

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

Details

Lead sponsor	National Heart Foundation of Bangladesh
Phase	PHASE4
Status	COMPLETED
Enrolment	1090
Start date	Sat Jan 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Mar 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Hypertension
• Potassium Imbalance

Interventions

• Fixed Dose Combination pill of Telmisartan 40mg and Amlodipine 5 mg

Countries

Bangladesh