PERSONAL-HTN v1.0
Research type
Research Study
Full title
Personalised Electronic Record Supported Optimisation of Amlodipine for Patients with Hypertension
IRAS ID
274133
Contact name
David Collier
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2019-004086-40
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study focuses on the dosing of amlodipine in adults who have high blood pressure in the UK. According to current NICE Guidelines, 30% of adults in the UK have hypertension. A third of these patients have blood pressure that is poorly controlled.Research has shown that lowering blood pressure can result in fewer heart attacks, strokes and deaths. Amlodipine is a medication that has been used for over two decades to treat hypertension. In the UK, amlodipine is available as a tablet in two doses: 5mg and 10mg. However, some patients have experienced side effects from taking amlodipine. The most commonly reported side effect is swelling in the ankles, feet and legs. This is known as peripheral oedema. In this study, we will provide amlodipine in a liquid form, in different doses (1mg, 2mg, 3mg, 4mg, 6mg, 7mg, 8mg and 9mg) to patients whose blood pressure is not adequately controlled in patients with hypertension, who have not been able to tolerate amlodipine 5mg or 10mg due to unwanted (side) effects.
The aim of the study is to explore whether gradually increasing the dose of liquid amlodipine in 1mg increments will help control blood pressure. We hope to recruit a total of 100 patients. In this case, this is liquid amlodipine. Patients will be grouped into two groups, one group will be patients who were previously intolerant of amlodipine 5mg and are currently not taking amlodipine. The second group are patients that are currently taking 5mg amlodipine tablets, and who will be transitioned to 5mg liquid amlodipine, and their dosage will be increased to 6mg liquid amlodipine and uptitrated progressively. The aim is to find the best dose of amlodipine for the individual patient. The effect of this adjustment is tested by comparing blood pressure measurements with 24hr monitors.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0039
Date of REC Opinion
20 Apr 2020
REC opinion
Further Information Favourable Opinion