EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. 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)

Timeline

Start

2012-02

Primary completion

2015-07

Completion

—

Publications

• Benitez-Camps M, Vinyoles-Bargallo E, Rebagliato-Nadal O, Morros-Pedros R, Pera-Pujadas H, Dalfo-Baque A, Lopez-Pavon I, Roca-Sanchez C, Coma-Carbo RM, De La Figuera Von Wichmann M, Mengual-Martinez L, Yuste-Marco C, Teixido-Colet M, Pepio i Vilaubi JM, Ciurana-Tost R, Pou-Vila R, Vila-Coll MA, Bordas-Julve JM, Aragones-Fores R, Pelegrina-Rodriguez FJ, Agudo-Ugena J, Blanco-Mata C, de la Iglesia Berrojalbiz J, Burgos-Alonso N, Gomez-Fernandez MC. Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial. BMC Cardiovasc Disord. 2015 Dec 10;15:167. doi: 10.1186/s12872-015-0161-7.

Drugs

Indications