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Occurrence of Dyskalemia With Treatment for Hypertension

NCT05155436 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1090

Last updated 2023-07-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

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

Participants without prevalent hyperkalemia will receive the fixed-dose combination pill of Telmisartan and Amlodipine, once daily for 3 months.

Sponsors & Collaborators

  • National Heart Foundation Hospital and Research Institute of Bangladesh

    collaborator UNKNOWN

  • Johns Hopkins University

    collaborator OTHER

  • Resolve to Save Lives

    collaborator OTHER

  • National Heart Foundation of Bangladesh

    lead OTHER

Principal Investigators

  • Fazilatunnesa Malik, MBBS, FCPS · National Heart Foundation, Bangladesh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-15
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Bangladesh

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155436 on ClinicalTrials.gov