HypertensionPhase 4NCT01047423
Targeting Microvascular Dysfunction in Young Hypertensive Patients
A Phase 4 study testing Simvastatin in people with Hypertension, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure. High blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Aug 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for the study, all of the following criteria must be met:
- All patients must have a diagnosis of essential hypertension with off treatment systolic pressure >140 mmHg and/or diastolic pressure >90 mmHg, measured at rest in the seated position on at least two separate occasions, at least 2 weeks apart.
- Patients will be < 50 years for men and < 60 years for women.
- Female patients of childbearing potential must be using a medically accepted means of contraception (that is, interuterine device, oral contraceptive, implant, DepoProvera or barrier devices). Female patients of childbearing age will be screened with a pregnancy test.
- Patients will be typically already on antihypertensive therapy.
- Patients must have a level of understanding sufficient to complete all tests and examinations required by the protocol and are able to understand and give informed consent.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- A history of diabetes mellitus, coronary artery or cerebrovascular disease, hypertensive retinopathy, hypertensive nephropathy, left ventricular hypertrophy or hyperlipidaemia warranting treatment as defined by the latest NICE guidelines which recommend an age based treatment strategy rather than one driven purely by lipid levels in isolation.
- Abnormal baseline liver function (defined as AST or ALT > 3 times upper limit of normal), raised baseline creatinine kinase (CK) (defined as CK > 200 mmol/L), severe renal impairment (defined as estimated glomerular filtration rate (eGFR) < 30 mls/minute) or previous adverse event relating to either an ARB or statin in the past.
- Female patients will be excluded if they are pregnant, intend to be pregnant or are lactating. Female patients of childbearing age will be screened with a pregnancy test.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Belfast health and social care trust
Belfast, BT9 7BL
About this study
Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure. High blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body. One way of detecting early changes in these blood vessels as a result of high blood pressure is to measure their compliance/flexibility with a noninvasive technique known as ultrasound and with a simple blood test. The investigators are trying to establish whether these early changes in blood vessels can be significantly improved by the use of both a cholesterol and blood pressure lowering tablet at an earlier stage than is currently advised. The investigators hope that the early combination of these tablets will prove more effective than the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk of long term complications developing.
- Conditions
- Hypertension
- Being tested
- Simvastatin, Placebo
- Keywords
- Hypertension endothelial dysfunction statin prevention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
40mg encapsulated once daily for 12 weeks
PlaceboDrug
Encapsulated oral once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | 40mg Simvastatin once daily for 12 weeks followed by 4 week washout period followed by placebo for 12 weeks Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | Placebo for 12 weeks followed by 4 week washout period followed by 40mg Simvastatin once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups.
Measured: 0, 3, 4 and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Principal investigator, Gary E McVeigh, Queen's University, Belfast
- Investigators
- Gary E McVeigh, FRCP PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047423
- Sponsor's protocol ID
- 2009-011638-90
- Other IDs
- 2009
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2010
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bleakley C, McCann A, McClenaghan V, Hamilton PK, Millar A, Pumb R, Harbinson M, McVeigh GE. Ultrasound entropy may be a new non-invasive measure of pre-clinical vascular damage in young hypertensive patients. Cardiovasc Ultrasound. 2015 Mar 20;13:12. doi: 10.1186/s12947-015-0006-7.
PubMed 25888961
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Microvascular Dysfunction in Young Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01047423
- Acronym / sponsor ID
- 2009-011638-90
- Conditions
- Hypertension
- Keywords
- Hypertension endothelial dysfunction statin prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 12 Jan 2010 (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.
Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure. High blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body. One way of detecting early changes in these blood vessels as a result of high blood pressure is to measure their compliance/flexibility with a noninvasive technique known as ultrasound and with a simple blood test. The investigators are trying to establish whether these early changes in blood vessels can be significantly improved by the use of both a cholesterol and blood pressure lowering tablet at an earlier stage than is currently advised. The investigators hope that the early combination of these tablets will prove more effective than the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk of long term complications developing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: Simvastatin40mg Simvastatin once daily for 12 weeks followed by 4 week washout period followed by placebo for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 12 weeks followed by 4 week washout period followed by 40mg Simvastatin once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- To be eligible for the study, all of the following criteria must be met:
Key exclusion criteria (4 listed)
- Patients will be excluded from the study if they meet any of the following criteria:
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 |
|---|---|---|
| Simvastatin40mg encapsulated once daily for 12 weeks | Drug | Simvastatin |
| PlaceboEncapsulated oral once daily for 12 weeks | Drug | Placebo |
Primary outcome
To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups.
Time frame: 0, 3, 4 and 7 months
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 5 Jul 2019.
- Derived from this study: PubMed 25888961Bleakley C, McCann A, McClenaghan V, Hamilton PK, Millar A, Pumb R, Harbinson M, McVeigh GE. Ultrasound entropy may be a new non-invasive measure of pre-clinical vascular damage in young hypertensive patients. Cardiovasc Ultrasound. 2015 Mar 20;13:12. doi: 10.1186/s12947-015-0006-7.
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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.
Gary E McVeigh, FRCP PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin in people with Hypertension, run by Queen's University, Belfast at 1 site 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 6 inclusion and 4 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups. (time frame: 0, 3, 4 and 7 months). 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 NCT01047423, which also lists 1 linked publication.
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 Jul 2019.