Personalised Electronic Record Supported Optimisation of Amlodipine for Patients With Hypertension

NCT06713785 | Withdrawn Phase 4 DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to assess precision dosing of amlodipine to deliver reductions in blood pressure in patients with primary hypertension and inadequate BP control by up-titration of amlodipine in 1mg increments

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• The difference in daytime ambulatory systolic blood pressure between baseline ABPM and post-titration ABPM on a personalized dose of amlodipine.

  pressure between baseline ABPM and post-titration ABPM on a personalized dose of amlodipine.

  End of study 1 year

Secondary Outcomes (8)

• Other clinically significant blood pressure measures which related to difference in measured blood pressure between baseline and EOS, especially AOBP clinic BP readings and home BP readings

  End of study 1 year

• Feasibility of collecting data using a digital diary

  End of study 1 year

• Collect patient reported outcome data including satisfaction with medication regime using digital diary

  Collect patient reported outcome data including satisfaction with medication regime using digital diary

• Patient feedback on the use of digital diary

  End of study 1 year

• Insight into number of patients achieving target BP of <135 and 85 at EOS

  End of study 1 year

Study Arms (2)

Amlodipine 0mg

OTHER

amlodipine dose 0mg Week 0 → 1mg Week 2 → 2mg Week 4 → 3mg Week 6 → 4mg Week 8 → 5mg Dose escalation to continue in 1mg increments to a maximum of 5mg

Drug: Amlodipine

Amlodipine 5mg

OTHER

amlodipine dose 5mg Week 0 → 6mg Week 2 → 7mg Week 4 → 8mg Week 6 → 9mg Week 8 → 10mg Dose escalation to continue in 1mg increments to a maximum of 10mg

Drug: Amlodipine

Interventions

Amlodipine DRUG

Amlodipine 1mg/ml Oral Solution

Amlodipine 0mg; Amlodipine 5mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥18 years to 75 years
• Able to give consent
• Possession of a smart phone
• Confirmed diagnosis of hypertension by NICE/BIHS criteria on either 24h ABPM or repeated home measures of blood pressure, at any time.
• Previous experience of amlodipine and unwanted effects of the drug
• Willing to be re-challenged with amlodipine (if off treatment) or to try a higher dose than the 5mg currently treated with.
• Sub-optimal blood pressure control defined as daytime ABPM average systolic blood pressure of 135mmHg or greater, and/or daytime ABPM average diastolic blood pressure of 85mmHg or greater.
• Stable antihypertensive medication (ie. no dose adjustments, new Rx or stopped Rx in last 4 weeks for CCB, 8 weeks for diuretics, ACEi, ARB).
• Patients may be taking other blood pressure lowering medication, but these must be kept stable during assessment of eligibility and for the duration of the trial (except where essential to maintain patient safety).

You may not qualify if:

• \- Unable to consent.
• Severe adverse reaction to amlodipine making re-challenge or dose increase unwise.
• Myocardial infarction, Acute Coronary Syndrome, stroke or Transient Ischaemic Attack in the 6 months prior to screening.
• Heart failure classed as NYHA class III or IV.
• Renal impairment with eGFR \< 30ml/minute.
• Participation in another clinical trial, where the patient has received IMP in the last 3 months, except for MRC Aim-Hy with established medications and where patients can be screened after 6 weeks from final visit.
• Pregnant or lactating or female of childbearing potential not using adequate contraception

Sponsors & Collaborators

• Queen Mary University of London: lead
• INNOVATEUK: collaborator
• Closed Loop Medicine Ltd: collaborator

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Collier, Dr

  Clinical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, open label

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: December 3, 2024
• Study Start: September 26, 2020
• Primary Completion: January 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Post-trial, timeframe unspecified
• Access Criteria: Approved authorised by CI and clinical/research team.