CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,090 enrolled
Drug / intervention
Fixed Dose Combination pill of Telmisartan 40mg and Amlodipine 5 mgdrug
Likely dose
Fixed Dose Combination pill of Telmisartan 40mg and Amlodipine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05155436
NCT05155436Phase 4Completed

Prevalence and Incidence of Dyskalemia in Hypertensive Patients Initiating a Fixed Dose Combination Pill of Telmisartan and Amlodipine

National Heart Foundation of Bangladesh·interventional·Posted Dec 13, 2021·Updated Jul 14, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBangladesh

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedDec 13, 2021
Enrollment StartJan 15, 2022
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.6 years ago

Interventions

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

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