Hypertension MedDRA version: 21.1 Level: LLT Classification code 10081425 Term: Arterial hypertension System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Amlodipine 1mg/ml Oral Solution SmPC
Product Name: Amlodipine 1mg/ml Oral Solution SmPC
Pharmaceutical Form: Oral solution
INN or Proposed INN: Amlodipine besilate
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years. 2. Informed consent. 3. Possession of a working smartphone that the participant is able to independently use. 4. Smartphone to support iOS versions 10.0 and newer or to support Android versions 5.0 (Lollipop) and newer. 5. Smartphone to have minimum storage space required to install the e-diary: 250MB. 6. The participant's smartphone must have enough memory to run the e-diary. 7. Either a) Confirmed diagnosis of hypertension by NICE/BIHS criteria on either 24h ABPM or repeated home measures of blood pressure. Or b) Current treatment with antihypertensive medication. For the intervention study cohort 1. Sub-optimal blood pressure control defined as average systolic blood pressure of 140mmHg or greater, and/or average diastolic blood pressure of 90mmHg or greater during the 5 days run-in period. 2. Stable antihypertensive medication during the assessment of eligibility. For the observational study cohort 1. Average systolic blood pressure of less than 140mmHg and/or average diastolic blood pressure of less than 90mmHg during the 5 days run-in period Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 185 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Known severe adverse reaction to amlodipine. 2. Currently receiving >=10mg /day amlodipine. 3. Participation in another clinical trial, where the patient has received IMP in the last three months, with the exception of the MRC Aim-Hy study (IRAS: 199550, REC: 16/EE/0294) where patients can be screened after 6 weeks from final visit. 4. Pregnant or lactating or female of childbearing potential not using adequate contraception (defined as oral contraceptive pill, IntraUterine Device, double barrier methods or abstinence as a clearly defined lifestyle choice). 5. Patients who have too limited or no understanding of spoken and/or written English in the opinion of the investigator 6. Patients who have hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients. 7. Patients with obstruction of the outflow tract of the left ventricle (e.g. high grade aortic grade stenosis). 8. Patients with a known intolerance of fructose, sugar, glycerol, maltitol liquid. (Liquid amlodipine is classed as sugar free, whereas the standard tablet contains lactose). 9. Co-morbidities incompatible with study participation e.g. that result in a participant being unable to complete daily entries satisfactorily via his/her smartphone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary research objective is to assess how effective precision dosing of amlodipine is in managing blood pressure in participants with primary hypertension and inadequate blood pressure control. Amlodipine will be up-titrated in 1-2mg increments, under a remote medical management protocol during the COVID-19 pandemic. This study will involve the use of a digital diary on which home blood pressure recording will be entered by the participant. During the early part of the study blood pressure recordings will be assessed by the study team to see if the participant should stay on their existing medication regime- if blood pressure is okay- or if blood pressure is raised, participants will be sent liquid amlodipine in the post and the dose of this will be adjusted with the aim of better blood pressure control. The study aims to test the effect of this extra medication regime- both before and after.;Secondary Objective: • Does blood pressure fall further in those given extra amlodipine, compared with those participants who started with better blood pressure control to start with. • Difference in home measured diastolic blood pressure between baseline and End of study. • Assess tolerability / side effects of study drug using a digital diary • Assess feasibility of collecting data using a digital diary. • Collect patient reported data including satisfaction with medication regime using digital diary and patient completed questionnaires on quality of life, beliefs about medicines and compliance. • Patient feedback on the use of digital diary at their last treatment consultation prior to their follow-up visit • Insight into number of patients achieving target BP of <140 and/or <90 at EOT. • Insight into number of patients achieving reduction in systolic BP of =5mmHg at EOT. • Insight into number of patients achieving reduction in systolic BP of =10mmHg EOT. • Insight into number of patients achi;Primary end point(s): The primary outcome of th | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other clinically significant blood pressure measures which related to difference in measured blood pressure between baseline and EOT;Timepoint(s) of evaluation of this end point: Mean change in daily DBP from baseline to end of treatment (EOT) | — |
Countries
United Kingdom
Contacts
Public ContactDr David Collier
Queen Mary University of London
Outcome results
None listed