HypertensionPhase 4PERSONAL HTNNCT06713785
Personalised Electronic Record Supported Optimisation of Amlodipine for Patients With Hypertension
A Phase 4 study testing Amlodipine in people with Hypertension, run by Queen Mary University of London.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2020to 31 May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
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- 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).
Who cannot join
- - 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
About this study
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
Read the detailed description
Hypertension is the leading preventable cause of premature death worldwide. Globally, 1.39bn people are estimated to have hypertension, and it caused ≈10.7 million deaths in 2015. It is projected to affect more than 1.5 billion people around the world by 2025.
In the UK ~30% of adults have hypertension3; 9.5m have a diagnosis, and a further 5m people in England alone may have hypertension yet be unaware. The annual incidence of new cases is 5-8%5. Physician inertia (inadequate up-titration of treatment, especially from monotherapy) and poor patient adherence to treatment (especially when based on multiple pills) are now recognised as major factors contributing to poor BP control.
Amlodipine is a calcium-channel blocking drug which reduces blood pressure by relaxing blood vessels (especially veins) but this same effect makes it prone to causing fluid accumulation (oedema) in the lower limbs. Approved by the FDA in the United States in 1987, there is a large amount of evidence on its effectiveness and safety in reducing blood pressure and in treating stable angina. There appears to be a close relationship between wanted and unwanted effects. Finding the best dose of amlodipine for a patient could be useful in optimizing their blood pressure treatment. At present the tablet doses available are only 5mg and 10mg in the UK.
In the present study the investigators will investigate the relationship between patient beliefs about medicines using the Beliefs about Medicines Questionnaire (BMQ) developed by Horne, Weinman and Hankins (1999)13 and their adherence using the Morisky Medication Adherence Scale - 8 14. The investigators hypothesize that patients' tolerability of side effects (as measured by VAS) will be related to their beliefs about the necessity of medication (necessity concerns), their concerns about side effects and their adherence to medication.
This study will only look at doses within the current maximum licensed 10mg dose. The investigators will ask patients who have had previous problems with unwanted effects of amlodipine at conventional doses to have careful monitoring of blood pressure over 24 hours using an ambulatory blood pressure monitor. If blood pressure control on their maximum tolerated conventional dose of amlodipine (0 or 5mg) is inadequate (systolic daytime average =>135 mmHg and/or diastolic daytime average =>85 mmHg), then patients will be eligible for the study. Those taking 5mg amlodipine tablets daily will be given amlodipine liquid to take at the same 5mg dose to convert to liquid formulation dosing. Patients will be issued with standard home blood pressure monitors and will be asked to measure their blood pressure in the morning (three readings) before taking their tablet (trough treatment) and again in the evening (three readings). Patients will attend every two weeks, following screening with clinical history taking, haematology, biochemistry, HbA1c, routine physical examination and resting ECG. Every two weeks patients will have clinic blood pressure measurements and review of home BP monitoring
- Conditions
- Hypertension
- Being tested
- Amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Amlodipine 1mg/ml Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: End of study 1 year
Feasibility of collecting data using a digital diary
Feasibility of collecting data using a digital diary
Measured: 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
Measured: Collect patient reported outcome data including satisfaction with medication regime using digital diary
Patient feedback on the use of digital diary
Patient feedback on the use of digital diary
Measured: End of study 1 year
Insight into number of patients achieving target BP of <135 and 85 at EOS
Insight into number of patients achieving target BP of <135 and 85 at EOS
Measured: End of study 1 year
Insight into number of patients achieving reduction in systolic BP of ≥5mmHg at EOS
Insight into number of patients achieving reduction in systolic BP of ≥5mmHg at EOS
Measured: End of Study
Insight into number of patients achieving reduction in systolic BP of ≥10mmHg EOS
Insight into number of patients achieving reduction in systolic BP of ≥10mmHg EOS
Measured: EOS 1 year
Insight into number of patients achieving reduction in diastolic BP of ≥5mmHg at EOS
Insight into number of patients achieving reduction in diastolic BP of ≥5mmHg at EOS
Measured: End of study 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start26 Sep 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 May 2021 (estimated)
Why it stopped: 4.09.2020 decided to close the PERSONAL-HTN study without recruiting any patients because its approval by MHRA and HRA under CWoW coincided with the COVID-19 pandemic and lockdown in England
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single site, open label
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- INNOVATEUK, Closed Loop Medicine Ltd
- Responsible party
- Sponsor
- Investigators
- David Collier, Dr, Principal investigator, Clinical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713785
- Sponsor's protocol ID
- 1
- Acronym
- PERSONAL HTN
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2019
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Main study findings will be published on websites of the cardiovascular unit at Barts. Following primary publication of the trial results, fully anonymized trial data can be made available to interested researchers on request to the Chief Investigator. The sponsor retains the right to review all publications prior to submission or publication. Responsibility for ensuring accuracy of any publication from this study is delegated to the Chief Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Electronic Record Supported Optimisation of Amlodipine for Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06713785
- Acronym / sponsor ID
- PERSONAL HTN / 1
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 4.09.2020 decided to close the PERSONAL-HTN study without recruiting any patients because its approval by MHRA and HRA under CWoW coincided with the COVID-19 pandemic and lockdown in England
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- INNOVATEUK, Closed Loop Medicine Ltd
- Study start
- 26 Sep 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Hypertension is the leading preventable cause of premature death worldwide. Globally, 1.39bn people are estimated to have hypertension, and it caused ≈10.7 million deaths in 2015. It is projected to affect more than 1.5 billion people around the world by 2025.
In the UK ~30% of adults have hypertension3; 9.5m have a diagnosis, and a further 5m people in England alone may have hypertension yet be unaware. The annual incidence of new cases is 5-8%5. Physician inertia (inadequate up-titration of treatment, especially from monotherapy) and poor patient adherence to treatment (especially when based on multiple pills) are now recognised as major factors contributing to poor BP control.
Amlodipine is a calcium-channel blocking drug which reduces blood pressure by relaxing blood vessels (especially veins) but this same effect makes it prone to causing fluid accumulation (oedema) in the lower limbs. Approved by the FDA in the United States in 1987, there is a large amount of evidence on its effectiveness and safety in reducing blood pressure and in treating stable angina. There appears to be a close relationship between wanted and unwanted effects. Finding the best dose of amlodipine for a patient could be useful in optimizing their blood pressure treatment. At present the tablet doses available are only 5mg and 10mg in the UK.
In the present study the investigators will investigate the relationship between patient beliefs about medicines using the Beliefs about Medicines Questionnaire (BMQ) developed by Horne, Weinman and Hankins (1999)13 and their adherence using the Morisky Medication Adherence Scale - 8 14. The investigators hypothesize that patients' tolerability of side effects (as measured by VAS) will be related to their beliefs about the necessity of medication (necessity concerns), their concerns about side effects and their adherence to medication.
This study will only look at doses within the current maximum licensed 10mg dose. The investigators will ask patients who have had previous problems with unwanted effects of amlodipine at conventional doses to have careful monitoring of blood pressure over 24 hours using an ambulatory blood pressure monitor. If blood pressure control on their maximum tolerated conventional dose of amlodipine (0 or 5mg) is inadequate (systolic daytime average =>135 mmHg and/or diastolic daytime average =>85 mmHg), then patients will be eligible for the study. Those taking 5mg amlodipine tablets daily will be given amlodipine liquid to take at the same 5mg dose to convert to liquid formulation dosing. Patients will be issued with standard home blood pressure monitors and will be asked to measure their blood pressure in the morning (three readings) before taking their tablet (trough treatment) and again in the evening (three readings). Patients will attend every two weeks, following screening with clinical history taking, haematology, biochemistry, HbA1c, routine physical examination and resting ECG. Every two weeks patients will have clinic blood pressure measurements and review of home BP monitoring
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single site, open label
| Arm | Type | Receives |
|---|---|---|
| Amlodipine 0mg | Other | Drug: Amlodipineamlodipine 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 |
| Amlodipine 5mg | Other | Drug: Amlodipineamlodipine 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - 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
Key exclusion criteria (7 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineAmlodipine 1mg/ml Oral Solution | Drug | Amlodipine 0mg, Amlodipine 5mg |
Primary outcome
The difference in daytime ambulatory systolic blood pressure between baseline ABPM and post-titration ABPM on a personalized dose of amlodipine.
Time frame: End of study 1 year
pressure between baseline ABPM and post-titration ABPM on a personalized dose of amlodipine.
8 secondary outcomes
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
Time frame: End of study 1 year
Feasibility of collecting data using a digital diary
Time frame: End of study 1 year
Collect patient reported outcome data including satisfaction with medication regime using digital diary
Time frame: Collect patient reported outcome data including satisfaction with medication regime using digital diary
Patient feedback on the use of digital diary
Time frame: End of study 1 year
Insight into number of patients achieving target BP of <135 and 85 at EOS
Time frame: End of study 1 year
Insight into number of patients achieving reduction in systolic BP of ≥5mmHg at EOS
Time frame: End of Study
Insight into number of patients achieving reduction in systolic BP of ≥10mmHg EOS
Time frame: EOS 1 year
Insight into number of patients achieving reduction in diastolic BP of ≥5mmHg at EOS
Time frame: End of study 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Yes. Main study findings will be published on websites of the cardiovascular unit at Barts. Following primary publication of the trial results, fully anonymized trial data can be made available to interested researchers on request to the Chief Investigator. The sponsor retains the right to review all publications prior to submission or publication. Responsibility for ensuring accuracy of any publication from this study is delegated to the Chief Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Collier, Dr principal investigator
Clinical Director
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine in people with Hypertension, run by Queen Mary University of London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in daytime ambulatory systolic blood pressure between baseline ABPM and post-titration ABPM on a personalized dose of amlodipine. (time frame: End of study 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.