Clinical Trials Register

Summary
EudraCT Number:	2020-002494-10
Sponsor's Protocol Code Number:
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	GB - no longer in EU/EEA
Date on which this record was first entered in the EudraCT database:	2020-06-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2020-002494-10

A.3

Full title of the trial

Personalised Electronic Record Supported OptimisatioN when ALone for Patients with Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

PERSONAL-COVIDBP

A.3.2

Name or abbreviated title of the trial where available

PERSONAL-COVIDBP

A.4.1

Sponsor's protocol code number

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Queen Mary University of London
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Innovate-UK
B.4.2	Country	United Kingdom
B.4.1	Name of organisation providing support	Closed Loop Medicine Ltd.
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Queen Mary University of London
B.5.2	Functional name of contact point	Dr David Collier
B.5.3	Address:
B.5.3.1	Street Address	William Harvey Research Institute Clinical Research Centre
B.5.3.2	Town/ city	London
B.5.3.3	Post code	EC1M 6BQ
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	07961 383925
B.5.6	E-mail	d.j.collier@qmul.ac.uk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Amlodipine 1mg/ml Oral Solution SmPC
D.2.1.1.2	Name of the Marketing Authorisation holder	Rosemont Pharmaceuticals
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Amlodipine 1mg/ml Oral Solution SmPC
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Amlodipine besilate
D.3.9.4	EV Substance Code	AS1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hypertension

E.1.1.1

Medical condition in easily understood language

Poorly controlled blood pressure

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10081425
E.1.2	Term	Arterial hypertension
E.1.2	System Organ Class	100000004866

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

• 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

E.2.3

Trial contains a sub-study

E.3

Principal 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

E.4

Principal 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.

E.5 End points

E.5.1

Primary end point(s)

The primary outcome of the study is the difference in systolic blood pressure between baseline BP and post-titration BP on a personalized dose of amlodipine.

E.5.1.1

Timepoint(s) of evaluation of this end point

Mean change in daily SBP (5 day average) from baseline to end of treatment (EOT)

E.5.2

Secondary end point(s)

Other clinically significant blood pressure measures which related to difference in measured blood pressure between baseline and EOT

E.5.2.1

Timepoint(s) of evaluation of this end point

Mean change in daily DBP from baseline to end of treatment (EOT)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

remote care with digital diary

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

observational cohort

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1