HypertensionPhase 4AIMHY-INFORMNCT02847338
Comparison of Optimal Hypertension Regimens
A Phase 4 study testing Amlodipine, Lisinopril and Amiloride in people with Hypertension, run by Cambridge University Hospitals NHS Foundation Trust at 14 sites in United Kingdom.
Trial summary
High blood pressure (Hypertension) is extremely common and is a major cause of heart disease, kidney disease and stroke. One in three of the UK (United Kingdom) population will require treatment for hypertension at some point in their lives. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine, Lisinopril and Amiloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 940 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- Nov 2016to Oct 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in the trial the participant must:
- Have given written informed consent to participate
- Be aged 18 to 65 years inclusive
- Self-Define Ethnicity: participants should SELF IDENTIFY into 1 of the three groups below:
- White White British White Irish Any other white background
- Black or Black British Black Caribbean Black African Any other black background
Show all 12Show fewer
- Asian or Asian British Asian Indian Asian Pakistani Asian Bangladeshi Any other Asian background
- Be hypertensive defined as:- Mono-therapy rotation
- currently untreated with EITHER an ABPM day time average blood pressure ≥ 135mmHG (systolic) or ≥ 85mmHg (diastolic) OR Home BP measurements using a validated device based on the average of 10 blood pressure readings of ≥135 mmHg (systolic) or ≥85 mmHg (diastolic)
- Patients who may be taking antihypertensive drugs at sub therapeutic doses or in ineffective combinations, and who are felt likely to be controllable on a study drug and willing and able to be washed out, at the discretion of the CI (Chief Investigator) / PI (Principal Investigator), can enter the trial if they meet the above criteria.
- Dual therapy rotation
- a.Treated hypertensive receiving one to three antihypertensive drugs with a blood pressure (ABPM daytime average blood pressure or Home BP as in a.) between 135 or 200 mmHg (systolic) AND between 85 or 110 mmHg (diastolic).
Who cannot join
- The presence of any of the following will mean participants are ineligible:
- Participant does not fit into one of the defined ethnic groups e.g. Mixed
- Pregnant or breastfeeding women
- Known or suspected secondary hypertension
- Significant sensitivity or contraindications to any of the study medications
- Participants taking lithium or are regularly consuming non-steroidal anti-inflammatory drugs at variable doses
Show all 11Show fewer
- Requirement to take any of the study drugs continuously e.g. ACEi and heart failure
- Any clinically significant hepatic impairment
- Any clinically significant kidney impairment
- Concurrent participation in another clinical trial using systemic vasoactive medications or medications known to interact with the study drugs (participation in another study as part of the AIM HY mechanistic or social science programme will not be an exclusion criterion)
- Patients who are deemed unsuitable by the investigator on clinical grounds
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Sandwell & West Birmingham Hospitals NHS Trust
Birmingham, B18 7QH
Heartlands Hospital
Birmingham, B9 5SS
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
University Hospital Llandough
Cardiff, CF64 2XX
University of Glasgow
Glasgow, G12 8TA
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
William Harvey Research Institute, Barts and the London Medical School
London, EC1M 6BQ
St Thomas' Hospital
London, SE1 7EH
St George's Hospital
London, SW17 0RE
Hammersmith & Fulham GP Partnership: Richford Gate Medical Practice
London, W6 7HL
Manchester Royal Infirmary
Manchester, M13 9WL
Nottingham University Hospital: QMC Campus
Nottingham, NG7 2UH
Lister Hospital
Stevenage, SG1 4AB
About this study
Official title: Comparison of Optimal Hypertension Regimens (Part of the Ancestry Informative Markers in Hypertension (AIMHY) Programme - AIMHY-INFORM)
High blood pressure (Hypertension) is extremely common and is a major cause of heart disease, kidney disease and stroke. One in three of the UK (United Kingdom) population will require treatment for hypertension at some point in their lives. A healthy lifestyle alone is often not enough to control blood pressure, and drug treatment is usually required. Although a wide variety of drugs are available to treat hypertension, choosing the right kind of tablet or combination of tablets for individual patients is a problem, and therefore many people have poor blood pressure control.
Hypertension treatment within the UK is currently selected according to age and self-defined ethnicity (SDE). There are limitations to this approach which include wide variability in the response to hypertension drug classes between people. There is also uncertainty about selecting hypertension drugs for ethnic minorities other than those of African/Caribbean ancestry, for example, South Asians because of a lack of information from trials. In the AIM HY-INFORM study the investigators are looking to recruit equal number of black/caribbean, south asian and white european participants to be able to compare differences in hypertension treatments and ethnicity.
The primary objective of this study is to determine if the response to antihypertensive drugs differs by self defined ethnicity.
Read the detailed description
In the UK, current NICE (National Institute for Health and Clinical Excellence) guidance stratifies hypertension treatment according to age and self-defined ethnicity (SDE). Different initial monotherapies are recommended for all those aged over 55 years, and for younger black compared to white individuals. However, there is no recommended stratification for combination therapy. The evidence based supporting the current guidance on SDE stratification is limited, and there is a specific lack of data from UK based populations.
Stratification based on SDE has a number of limitations and an alternative approach is stratification based on ancestry informative markers (AIM). There are genetic polymorphisms, which show substantially different frequencies between populations from different geographical regions, and can predict geographical ancestry with remarkable accuracy. AIM are thus more likely to capture the genetic component of variation in drug response in ethnically diverse population.
Metabolomic profiling of plasma and urine may provide complementary information to AIM, as differences between individuals will reflect both genetic and environmental influences. To address these issues the investigators intend to compare the variation in response to antihypertensive drug treatments in three SDE cohorts, and relate this to variation in AIM and metabolomic profiles. Our objective is to test the validity of current NICE guidance on antihypertensives stratification based on SDE, to provide evidence about SDE stratification for dual therapy, and to examine whether more effective personalisation of antihypertensive treatment, can be achieved using AIM and/or metabolomic profiling.
An assessment of patient stratification based on AIM phenotypes against SDE will enable the selection of optimal and more effective choices of anti-hypertensive treatments from currently existing first line drugs (and combinations of) and ultimately reduce the attrition of antihypertensive therapies.
Output from the trial will provide the first perspective evidence for best treatment choice according to SDE for white, black and asian populations in the UK. This should reduce the number of consultations; time required to achieve optimal blood pressure control and the contribution to between hypertension control in the UK.
Patients in the trial will be enrolled on a monotherapy or dual therapy regime depending on their history of hypertension. The monotherapy group of patients will enter a randomised, open-label, three-treatment three-period cross over trial.
The dual therapy group of patients will enter a randomised, open-label, four-treatment four-period cross over trial.
Randomisation, for each crossover design, will be stratified by three SDE groups.
The duration for individual participants will be approximately 24 (monotherapy) or 32 weeks (dual therapy)
The hypertensive medication used in this trial are:
Amlodipine 5 or 10mg, Chlortalidone 25mg, Amiloride 10mg, Lisinopril 10 or 20mg,
Participants on the dual therapy treatment arm will have a total of 11 visits including screening/enrolment (visit 1) and baseline visit (visit 2)
Participants on the monotherapy treatment arm will have a total of 9 visits including screening/enrolment (visit 1) and baseline visit (visit 2)
A total number of 1320 participants will be enrolled in the study across participating sites, so that approximately 660 participants in each therapy regime (approximately 220 participants per ethnic group) complete the trial.
An optional skin-sodium investigation will be conducted at selected sites only where capacity and capability to complete the sub study investigations is demonstrated. The sub study aims to recruit up to 60 participants who have already given consent for the main AIM HY INFORM Trial. Consent for the optional sub-study will be obtained separately.
The investigation comprises two optional assessments: a skin biopsy and a sodium magnetic resonance imaging (23Na MRI) scan. Both assessments will be used to quantify skin sodium levels. Participants in the mono and dual therapy arms can elect to have the skin biopsy, the MRI scan, or both, at the baseline visit. Participants in the mono therapy arm only, can elect to have the skin biopsy, the MRI scan, or both, following completion of the amlodipine (A) and chlortalidone (C) study arms. The additional measurements are not anticipated to take more than approximately 2 hours.
- Conditions
- Hypertension
- Being tested
- Amlodipine, Lisinopril, Amiloride, Chlortalidone
- Keywords
- Hypertension
- 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 5mg and Amlodipine 10mg will be one of the treatments in which patients will receive on the monotherapy arm and on the dual therapy arm.
LisinoprilDrug
Lisinopril 10mg and Lisinopril 20mg will be one of the treatments in which patients will receive on the monotherapy arm.
Lisinopril 20mg will be one of the treatments in which patients will receive on the dual therapy arm.
AmilorideDrug
Amiloride 10mg will be one of the treatments in which patients will receive on the dual therapy arm.
ChlortalidoneDrug
Chlortalidone 25mg will be one of the treatments in which patients will receive on the dual therapy arm and monotherapy arm.
| Study group | Role | What they receive |
|---|---|---|
| Mono-therapy group | Experimental | The monotherapy group will be treated with the following treatments:
A) 1 to 2 weeks of Amlodipine 5mg followed by 6 to 7 weeks of Amlodipine 10mg B) 1 to 2 weeks of Lisinopril 10mg followed by 6 to 7 weeks of Lisinopril 20mg C) Approximately 8 weeks of 25mg Chlortalidone
Participants will be randomly allocated to one of six possible sequences of treatments of the three-treatment-three period Williams design: ABC, ACB, BAC, BCA, CAB, and CBA. Receives: Drug: Amlodipine; Drug: Lisinopril; Drug: Chlortalidone |
| Dual-therapy arm | Experimental | The dual-therapy group will be treated with the following treatments:
A) Approximately 8 weeks of Amlodipine 5mg and Lisinopril 20mg B) Approximately 8 weeks of Amlodipine 5mg and Chlortalidone 25mg C) Approximately 8 weeks of Lisinopril 20mg and Chlortalidone 25mg D) Approximately 8 weeks of Amiloride 10mg and Chlortalidone 25mg
Participants will be randomly allocated to one of four possible sequences of treatments of the four-treatment four-period Williams design: ABDC, BCAD, CDBA, and DACB. Receives: Drug: Amlodipine; Drug: Lisinopril; Drug: Amiloride; Drug: Chlortalidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated Automated Office Systolic Blood Pressure
This is planned for all participants
Measured: Approximately 8 weeks after receiving each treatment up to week 24 for mono therapy patients and up to week 32 for dual therapy patients
Secondary outcomes (5)
Seated Automatic office systolic blood pressure
This is planned for all participants
Measured: At every visit - every 4 weeks up to week 24 for mono therapy patients and every 4 weeks up to week 32 for dual therapy patients. From screening until last visit.
Core Cardiovascular Measurements
This is planned for all participants, but is only mandatory at baseline
Measured: Core cardiovascular measurements will be performed on all participants at Baseline. For all patients there is an option for them to have the measurements repeated at weeks 8, 16, 24 Mono&Dual and week 32 Dual only, these subsequent visits are optional.
Detailed Self Defined Ethnicity
This is planned for all participants
Measured: Screening visit only
Ambulatory Blood Pressure and/or blood pressure
This is planned for a subgroup of patients who agree to participate in the sub-study
Measured: This will be measured for a subgroup of patients at Baseline, week 8, week 16, week 24 Dual&Mono & week 32 Dual only
Optional Cardiovascular measures
This is planned for a subgroup of patients who agree to participate in the sub-study
Measured: These measurements will be performed on a subgroup of patients at Baseline, week 8, week 16, week 24 Dual&Mono & week 32 Dual only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2023
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Dr Ian B Wilkinson, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Ian Wilkinson, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847338
- Sponsor's protocol ID
- AO94005
- Acronym
- AIMHY-INFORM
- Status last verified
- Aug 2025
- First submitted
- 30 Jun 2016
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Only after the investigator has finished with the data and not patient identifiable data
Publications
Wych J, Grayling MJ, Mander AP. Sample size re-estimation in crossover trials: application to the AIM HY-INFORM study. Trials. 2019 Dec 2;20(1):665. doi: 10.1186/s13063-019-3724-6.
PubMed 31791376Mukhtar O, Cheriyan J, Cockcroft JR, Collier D, Coulson JM, Dasgupta I, Faconti L, Glover M, Heagerty AM, Khong TK, Lip GYH, Mander AP, Marchong MN, Martin U, McDonnell BJ, McEniery CM, Padmanabhan S, Saxena M, Sever PJ, Shiel JI, Wych J, Chowienczyk PJ, Wilkinson IB. A randomized controlled crossover trial evaluating differential responses to antihypertensive drugs (used as mono- or dual therapy) on the basis of ethnicity: The comparIsoN oF Optimal Hypertension RegiMens; part of the Ancestry Informative Markers in HYpertension program-AIM-HY INFORM trial. Am Heart J. 2018 Oct;204:102-108. doi: 10.1016/j.ahj.2018.05.006. Epub 2018 May 20.
PubMed 30092411
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optimal Hypertension Regimens (Part of the Ancestry Informative Markers in Hypertension (AIMHY) Programme - AIMHY-INFORM)
- ClinicalTrials.gov ID
- NCT02847338
- Acronym / sponsor ID
- AIMHY-INFORM / AO94005
- Conditions
- Hypertension
- Keywords
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Nov 2016
- Primary completion
- Oct 2023 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
High blood pressure (Hypertension) is extremely common and is a major cause of heart disease, kidney disease and stroke. One in three of the UK (United Kingdom) population will require treatment for hypertension at some point in their lives. A healthy lifestyle alone is often not enough to control blood pressure, and drug treatment is usually required. Although a wide variety of drugs are available to treat hypertension, choosing the right kind of tablet or combination of tablets for individual patients is a problem, and therefore many people have poor blood pressure control.
Hypertension treatment within the UK is currently selected according to age and self-defined ethnicity (SDE). There are limitations to this approach which include wide variability in the response to hypertension drug classes between people. There is also uncertainty about selecting hypertension drugs for ethnic minorities other than those of African/Caribbean ancestry, for example, South Asians because of a lack of information from trials. In the AIM HY-INFORM study the investigators are looking to recruit equal number of black/caribbean, south asian and white european participants to be able to compare differences in hypertension treatments and ethnicity.
The primary objective of this study is to determine if the response to antihypertensive drugs differs by self defined ethnicity.
Detailed description
In the UK, current NICE (National Institute for Health and Clinical Excellence) guidance stratifies hypertension treatment according to age and self-defined ethnicity (SDE). Different initial monotherapies are recommended for all those aged over 55 years, and for younger black compared to white individuals. However, there is no recommended stratification for combination therapy. The evidence based supporting the current guidance on SDE stratification is limited, and there is a specific lack of data from UK based populations.
Stratification based on SDE has a number of limitations and an alternative approach is stratification based on ancestry informative markers (AIM). There are genetic polymorphisms, which show substantially different frequencies between populations from different geographical regions, and can predict geographical ancestry with remarkable accuracy. AIM are thus more likely to capture the genetic component of variation in drug response in ethnically diverse population.
Metabolomic profiling of plasma and urine may provide complementary information to AIM, as differences between individuals will reflect both genetic and environmental influences. To address these issues the investigators intend to compare the variation in response to antihypertensive drug treatments in three SDE cohorts, and relate this to variation in AIM and metabolomic profiles. Our objective is to test the validity of current NICE guidance on antihypertensives stratification based on SDE, to provide evidence about SDE stratification for dual therapy, and to examine whether more effective personalisation of antihypertensive treatment, can be achieved using AIM and/or metabolomic profiling.
An assessment of patient stratification based on AIM phenotypes against SDE will enable the selection of optimal and more effective choices of anti-hypertensive treatments from currently existing first line drugs (and combinations of) and ultimately reduce the attrition of antihypertensive therapies.
Output from the trial will provide the first perspective evidence for best treatment choice according to SDE for white, black and asian populations in the UK. This should reduce the number of consultations; time required to achieve optimal blood pressure control and the contribution to between hypertension control in the UK.
Patients in the trial will be enrolled on a monotherapy or dual therapy regime depending on their history of hypertension. The monotherapy group of patients will enter a randomised, open-label, three-treatment three-period cross over trial.
The dual therapy group of patients will enter a randomised, open-label, four-treatment four-period cross over trial.
Randomisation, for each crossover design, will be stratified by three SDE groups.
The duration for individual participants will be approximately 24 (monotherapy) or 32 weeks (dual therapy)
The hypertensive medication used in this trial are:
Amlodipine 5 or 10mg, Chlortalidone 25mg, Amiloride 10mg, Lisinopril 10 or 20mg,
Participants on the dual therapy treatment arm will have a total of 11 visits including screening/enrolment (visit 1) and baseline visit (visit 2)
Participants on the monotherapy treatment arm will have a total of 9 visits including screening/enrolment (visit 1) and baseline visit (visit 2)
A total number of 1320 participants will be enrolled in the study across participating sites, so that approximately 660 participants in each therapy regime (approximately 220 participants per ethnic group) complete the trial.
An optional skin-sodium investigation will be conducted at selected sites only where capacity and capability to complete the sub study investigations is demonstrated. The sub study aims to recruit up to 60 participants who have already given consent for the main AIM HY INFORM Trial. Consent for the optional sub-study will be obtained separately.
The investigation comprises two optional assessments: a skin biopsy and a sodium magnetic resonance imaging (23Na MRI) scan. Both assessments will be used to quantify skin sodium levels. Participants in the mono and dual therapy arms can elect to have the skin biopsy, the MRI scan, or both, at the baseline visit. Participants in the mono therapy arm only, can elect to have the skin biopsy, the MRI scan, or both, following completion of the amlodipine (A) and chlortalidone (C) study arms. The additional measurements are not anticipated to take more than approximately 2 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mono-therapy group | Experimental | Drug: Amlodipine, Drug: Lisinopril, Drug: ChlortalidoneThe monotherapy group will be treated with the following treatments: A) 1 to 2 weeks of Amlodipine 5mg followed by 6 to 7 weeks of Amlodipine 10mg B) 1 to 2 weeks of Lisinopril 10mg followed by 6 to 7 weeks of Lisinopril 20mg C) Approximately 8 weeks of 25mg Chlortalidone Participants will be randomly allocated to one of six possible sequences of treatments of the three-treatment-three period Williams design: ABC, ACB, BAC, BCA, CAB, and CBA. |
| Dual-therapy arm | Experimental | Drug: Amlodipine, Drug: Lisinopril, Drug: Amiloride, Drug: ChlortalidoneThe dual-therapy group will be treated with the following treatments: A) Approximately 8 weeks of Amlodipine 5mg and Lisinopril 20mg B) Approximately 8 weeks of Amlodipine 5mg and Chlortalidone 25mg C) Approximately 8 weeks of Lisinopril 20mg and Chlortalidone 25mg D) Approximately 8 weeks of Amiloride 10mg and Chlortalidone 25mg Participants will be randomly allocated to one of four possible sequences of treatments of the four-treatment four-period Williams design: ABDC, BCAD, CDBA, and DACB. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have given written informed consent to participate
- Be aged 18 to 65 years inclusive
- Self-Define Ethnicity: participants should SELF IDENTIFY into 1 of the three groups below:
- White White British White Irish Any other white background
- Black or Black British Black Caribbean Black African Any other black background
Key exclusion criteria (11 listed)
- Participant does not fit into one of the defined ethnic groups e.g. Mixed
- Pregnant or breastfeeding women
- Known or suspected secondary hypertension
- Significant sensitivity or contraindications to any of the study medications
- Participants taking lithium or are regularly consuming non-steroidal anti-inflammatory drugs at variable doses
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 5mg and Amlodipine 10mg will be one of the treatments in which patients will receive on the monotherapy arm and on the dual therapy arm. | Drug | Dual-therapy arm, Mono-therapy group |
| LisinoprilLisinopril 10mg and Lisinopril 20mg will be one of the treatments in which patients will receive on the monotherapy arm. Lisinopril 20mg will be one of the treatments in which patients will receive on the dual therapy arm. | Drug | Dual-therapy arm, Mono-therapy group |
| AmilorideAmiloride 10mg will be one of the treatments in which patients will receive on the dual therapy arm. | Drug | Dual-therapy arm |
| ChlortalidoneChlortalidone 25mg will be one of the treatments in which patients will receive on the dual therapy arm and monotherapy arm. | Drug | Dual-therapy arm, Mono-therapy group |
Primary outcome
Seated Automated Office Systolic Blood Pressure
Time frame: Approximately 8 weeks after receiving each treatment up to week 24 for mono therapy patients and up to week 32 for dual therapy patients
This is planned for all participants
5 secondary outcomes
Seated Automatic office systolic blood pressure
Time frame: At every visit - every 4 weeks up to week 24 for mono therapy patients and every 4 weeks up to week 32 for dual therapy patients. From screening until last visit.
Core Cardiovascular Measurements
Time frame: Core cardiovascular measurements will be performed on all participants at Baseline. For all patients there is an option for them to have the measurements repeated at weeks 8, 16, 24 Mono&Dual and week 32 Dual only, these subsequent visits are optional.
Detailed Self Defined Ethnicity
Time frame: Screening visit only
Ambulatory Blood Pressure and/or blood pressure
Time frame: This will be measured for a subgroup of patients at Baseline, week 8, week 16, week 24 Dual&Mono & week 32 Dual only
Optional Cardiovascular measures
Time frame: These measurements will be performed on a subgroup of patients at Baseline, week 8, week 16, week 24 Dual&Mono & week 32 Dual only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 31791376Wych J, Grayling MJ, Mander AP. Sample size re-estimation in crossover trials: application to the AIM HY-INFORM study. Trials. 2019 Dec 2;20(1):665. doi: 10.1186/s13063-019-3724-6.
- Derived from this study: PubMed 30092411Mukhtar O, Cheriyan J, Cockcroft JR, Collier D, Coulson JM, Dasgupta I, Faconti L, Glover M, Heagerty AM, Khong TK, Lip GYH, Mander AP, Marchong MN, Martin U, McDonnell BJ, McEniery CM, Padmanabhan S, Saxena M, Sever PJ, Shiel JI, Wych J, Chowienczyk PJ, Wilkinson IB. A randomized controlled crossover trial evaluating differential responses to antihypertensive drugs (used as mono- or dual therapy) on the basis of ethnicity: The comparIsoN oF Optimal Hypertension RegiMens; part of the Ancestry Informative Markers in HYpertension program-AIM-HY INFORM trial. Am Heart J. 2018 Oct;204:102-108. doi: 10.1016/j.ahj.2018.05.006. Epub 2018 May 20.
- Individual participant dataSharing planned: Yes. Only after the investigator has finished with the data and not patient identifiable data
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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.
Ian Wilkinson principal investigator
Cambridge University Hospitals NHS Foundation Trust
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine, Lisinopril and Amiloride in people with Hypertension, run by Cambridge University Hospitals NHS Foundation Trust at 14 sites in United Kingdom.
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 12 inclusion and 11 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: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seated Automated Office Systolic Blood Pressure (time frame: Approximately 8 weeks after receiving each treatment up to week 24 for mono therapy patients and up to week 32 for dual therapy patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847338, which also lists 2 linked publications.
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 5 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.