MedTrace Logo

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

NCT02514538 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-08-03

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Non- effervescent Paracetamol kern

1g

DRUG

Effervescent paracetamol termalgin

1 g

Sponsors & Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-07-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02514538 on ClinicalTrials.gov