PERSONAL-COVIDBP

Phase 1

• Conditions: Hypertension; MedDRA version: 21.1Level: LLTClassification code 10081425Term: Arterial hypertensionSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-002494-10-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-08
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified