Blood PressurePhase 4PATH-BPNCT01997112
PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
A Phase 4 study testing Paracetamol in people with Blood Pressure, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old, men or post-menopausal women (women with no periods for 12 months or more, or those who have had a surgical menopause)
- Treated hypertensive patients with an average daytime ambulatory blood pressure measurement (ABPM) <150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM ≥135/85 but <150/95.
Who cannot join
- History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST>50IU/L) or stage 3-5 chronic kidney disease.
- History of overdose or suicidal ideation
- Patients weighing <55kgs.
- Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Centre, Western General Hospital
Edinburgh, City Of Edinburgh, EH4 2XU
About this study
The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.
Read the detailed description
A prospective randomised, double-blind, crossover trial, comparing the effects of paracetamol 1g (500mg x2) four times daily with matched placebo on ambulatory and clinic BP, each given for 14 days, with a 14-day washout period.
- Conditions
- Blood Pressure
- Being tested
- Paracetamol, Placebo oral capsule
- Keywords
- Blood pressure, Hypertension, Paracetamol, Acetaminophen
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
Placebo oral capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | paracetamol 1g (500mg x2) four times daily for 14 day period Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic ambulatory blood pressure
Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.
Measured: 14 days
Secondary outcomes (2)
Systolic clinic blood pressure
Difference in systolic clinic BP between the paracetamol and placebo treated groups.
Measured: 14 days
Diastolic ambulatory blood pressure
Difference in mean daytime diastolic ambulatory BP between the paracetamol and placebo treated groups.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion4 Jun 2019
- Study completionOct 2019
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 Blood PressureStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, National Health Service, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997112
- Sponsor's protocol ID
- PATHBP_2013
- Other IDs
- PG/13/26/3012 8
- Acronym
- PATH-BP
- Status last verified
- Oct 2019
- First submitted
- 21 Nov 2013
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
MacIntyre IM, Turtle EJ, Farrah TE, Graham C, Dear JW, Webb DJ; PATH-BP (Paracetamol in Hypertension-Blood Pressure) Investigators*. Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial. Circulation. 2022 Feb 8;145(6):416-423. doi: 10.1161/CIRCULATIONAHA.121.056015. Epub 2022 Feb 7.
PubMed 35130054
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
- ClinicalTrials.gov ID
- NCT01997112
- Acronym / sponsor ID
- PATH-BP / PATHBP_2013
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Hypertension, Paracetamol, Acetaminophen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation, National Health Service, United Kingdom
- Study start
- Jan 2014
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 27 Nov 2013 (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.
The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.
Detailed description
A prospective randomised, double-blind, crossover trial, comparing the effects of paracetamol 1g (500mg x2) four times daily with matched placebo on ambulatory and clinic BP, each given for 14 days, with a 14-day washout period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: Paracetamolparacetamol 1g (500mg x2) four times daily for 14 day period |
| Placebo | Placebo comparator | Drug: Placebo oral capsuleMatched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years old, men or post-menopausal women (women with no periods for 12 months or more, or those who have had a surgical menopause)
- Treated hypertensive patients with an average daytime ambulatory blood pressure measurement (ABPM) <150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM ≥135/85 but <150/95.
Key exclusion criteria (4 listed)
- History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST>50IU/L) or stage 3-5 chronic kidney disease.
- History of overdose or suicidal ideation
- Patients weighing <55kgs.
- Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.
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 |
|---|---|---|
| ParacetamolAlso: Acetaminophen | Drug | Paracetamol |
| Placebo oral capsule | Drug | Placebo |
Primary outcome
Systolic ambulatory blood pressure
Time frame: 14 days
Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.
2 secondary outcomes
Systolic clinic blood pressure
Time frame: 14 days
Diastolic ambulatory blood pressure
Time frame: 14 days
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 2 Oct 2019.
- Derived from this study: PubMed 35130054MacIntyre IM, Turtle EJ, Farrah TE, Graham C, Dear JW, Webb DJ; PATH-BP (Paracetamol in Hypertension-Blood Pressure) Investigators*. Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial. Circulation. 2022 Feb 8;145(6):416-423. doi: 10.1161/CIRCULATIONAHA.121.056015. Epub 2022 Feb 7.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Paracetamol in people with Blood Pressure, run by University of Edinburgh 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 2 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: finished, as of the sponsor's last update on 2 Oct 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 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?
Systolic ambulatory blood pressure (time frame: 14 days). 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 NCT01997112, 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 2 Oct 2019.