CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21,922 enrolled
Drug / intervention
Evidence-based fixed-dose combination protocol based treatmentother
Likely dose
Not stated in 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/NCT04158154
NCT04158154N/ACompleted

Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

Washington University School of Medicine·interventional·Posted Nov 8, 2019·Updated May 20, 2025

In Brief

A clinical study evaluating Evidence-based fixed-dose combination protocol based treatment for Hypertension. Completed, enrolled 21,922 participants across 60 sites.

Detailed Summary

The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesNigeria

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 8, 2019
Enrollment StartFeb 1, 2020
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.6 years ago

Interventions

Evidence-based fixed-dose combination protocol based treatmentother

The intervention has been adapted based on a local needs' assessment including exploration of health care workers and patient's knowledge, attitudes, and behaviors related to HTN, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable barriers to HTN treatment and control across capability, intentional, and system domains using CFIR. Sites will randomly be assigned to receive either: Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 2 separate pills); Step 3 amlodipine 10 mg + losartan 100 mg (as 4 separate pills); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo) or Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 1 single pill combo); Step 3 amlodipine 10 mg + losartan 100 mg (as 2 single pill combo); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo).