NCT01997112CompletedPhase 4
PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Systolic ambulatory blood pressure
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Paracetamol
Active Comparator
paracetamol 1g (500mg x2) four times daily for 14 day period
Intervention: Paracetamol (Drug)
Placebo
Placebo Comparator
Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days
Intervention: Placebo oral capsule (Drug)
Outcomes
Primary Outcomes
Systolic ambulatory blood pressure
Time Frame: 14 days
Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups.
Secondary Outcomes
- Systolic clinic blood pressure(14 days)
- Diastolic ambulatory blood pressure(14 days)
Investigators
Study Sites (1)
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