EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL. — Paracetamol  

Hypertension Clinical Trial

Official title: EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL.

Status Active, not recruiting

Clinical Trial Summary

Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor.

Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients.

This is a multicenter, randomized, controlled, crossover, open, phase IV clinical trial, which compares the effect of two different formulations of paracetamol (effervescent or non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks treatment (coded EUDRACT 2010-023485-53). The washing time between the two periods is approximately 1 week (minimum 3 days)

Clinical Trial Description

Inclusion criteria:

Patients included in the study must meet the following criteria:

• be hypertensive patients over 18 years

• with degenerative joint disease

• which regularly need analgesic treatment. They must submit BP in the consultation lower than 150 and 95 mmHg or lower than 135 and 85 mmHg if they have associated cardiovascular disease (stroke, coronary heart disease, peripheral arterial disease) or diabetes mellitus.

They can't receive pharmacological antihypertensive treatment, or this must be stable and unchanged in the last month.

In relation to osteoarticular disease, they should have a degree of mild to moderate pain, with a score between 1 and 4 on a visual analog scale (VAS)

Evaluation of results

Primary endpoint:

The primary endpoint is the change in mean daytime, night-time (sleep) and 24-hour systolic BP, measured by ABPM, from baseline at 3 weeks of treatment in both periods.

Secondary endpoints:

• Changes in systolic BP measured in the clinic at the end of 3-week follow-up respect baseline in both periods.

• 24-hour, daytime and night-time (sleep) diastolic BP measured by ABPM: change from baseline at 3 weeks of treatment in both periods

• Changes in diastolic BP measured in the clinic at the end of 3-week follow-up respect baseline in both periods.

• Percentage of patients maintaining clinical BP under 140 and 90 mmHg at the end of each period

• Degree of pain assessed by visual analog scale

• Consumption of rescue medication

• Therapeutic compliance ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Disease of Musculoskeletal System
• Hypertension

• NCT number: NCT02514538
• Study type: Interventional
• Source: Jordi Gol i Gurina Foundation
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 2012