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Comparison of Optimal Hypertension Regimens

NCT02847338 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 940

Last updated 2025-09-05

No results posted yet for this study

Summary

High blood pressure (Hypertension) is extremely common and is a major cause of heart disease, kidney disease and stroke. One in three of the UK (United Kingdom) population will require treatment for hypertension at some point in their lives. A healthy lifestyle alone is often not enough to control blood pressure, and drug treatment is usually required. Although a wide variety of drugs are available to treat hypertension, choosing the right kind of tablet or combination of tablets for individual patients is a problem, and therefore many people have poor blood pressure control.

Hypertension treatment within the UK is currently selected according to age and self-defined ethnicity (SDE). There are limitations to this approach which include wide variability in the response to hypertension drug classes between people. There is also uncertainty about selecting hypertension drugs for ethnic minorities other than those of African/Caribbean ancestry, for example, South Asians because of a lack of information from trials. In the AIM HY-INFORM study the investigators are looking to recruit equal number of black/caribbean, south asian and white european participants to be able to compare differences in hypertension treatments and ethnicity.

The primary objective of this study is to determine if the response to antihypertensive drugs differs by self defined ethnicity.

Conditions

Interventions

DRUG

Amlodipine

Amlodipine 5mg and Amlodipine 10mg will be one of the treatments in which patients will receive on the monotherapy arm and on the dual therapy arm.

DRUG

Lisinopril

Lisinopril 10mg and Lisinopril 20mg will be one of the treatments in which patients will receive on the monotherapy arm. Lisinopril 20mg will be one of the treatments in which patients will receive on the dual therapy arm.

DRUG

Amiloride

Amiloride 10mg will be one of the treatments in which patients will receive on the dual therapy arm.

DRUG

Chlortalidone

Chlortalidone 25mg will be one of the treatments in which patients will receive on the dual therapy arm and monotherapy arm.

Sponsors & Collaborators

Principal Investigators

  • Ian Wilkinson · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • United Kingdom

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 NCT02847338 on ClinicalTrials.gov