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PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study (PATH-BP)

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ClinicalTrials.gov Identifier: NCT01997112
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
British Heart Foundation
National Health Service, United Kingdom
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.

Condition or disease Intervention/treatment Phase
Blood Pressure Drug: Paracetamol Drug: Placebo oral capsule Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
Study Start Date : January 2014
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Paracetamol
paracetamol 1g (500mg x2) four times daily for 14 day period
Drug: Paracetamol
Other Name: Acetaminophen

Placebo Comparator: Placebo
Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days
Drug: Placebo oral capsule



Primary Outcome Measures :
  1. Systolic ambulatory blood pressure [ Time Frame: 14 days ]
    Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.


Secondary Outcome Measures :
  1. Systolic clinic blood pressure [ Time Frame: 14 days ]
    Difference in systolic clinic BP between the paracetamol and placebo treated groups.

  2. Diastolic ambulatory blood pressure [ Time Frame: 14 days ]
    Difference in mean daytime diastolic ambulatory BP between the paracetamol and placebo treated groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997112


Locations
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United Kingdom
Clinical Research Centre, Western General Hospital
Edinburgh, City Of Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
National Health Service, United Kingdom
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01997112    
Other Study ID Numbers: PATHBP_2013
PG/13/26/3012 8 ( Other Grant/Funding Number: British Heart Foundation )
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Edinburgh:
Blood pressure
Hypertension
Paracetamol
Acetaminophen
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics