A Phase 4 interventional study of Non- effervescent Paracetamol kern and Effervescent paracetamol termalgin in Hypertension and Chronic Disease of Musculoskeletal System, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-03.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Phase 4, Interventional, and Treatment
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)
Inclusion criteria:
Patients included in the study must meet the following criteria:
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:
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 49 is below the median of 120 across 722 interventional studies indexed under Chronic Disease.
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They can't receive pharmacological antihypertensive treatment, or this must be stable and unchanged in the last month.
In relation to degenerative joint disease, they should have a degree of mild to moderate pain, with a score between 1 and 4 on a visual analog scale (VAS)
Exclusion Criteria:
Patients with heart failure due to systolic and / or diastolic dysfunction will also be excluded, those who have suffered a cardiovascular event (myocardial infarction, unstable angina or stroke of any type) in the last 6 months, presenting sleep apnea or any form of secondary hypertension, elevated transaminases (higher than 3 times normal value), or a glomerular filtration rate \<30 ml/min, over a maximum period of three months before starting the study; patients with dementia or judicial disability, with alcoholism or other addictions; pregnant patients; patients treated with oral anticoagulants or subcutaneous heparin. Patients in which changes are foreseen in usual dose drugs with effects on BP throughout the study (alpha blockers, tricyclic antidepressants, beta blockers in eye drops, sympathomimetic vasoconstrictor, other effervescent agents, hormonal contraceptives, NSAIDs, corticosteroids, anabolic, erythropoietin, cyclosporine) or those who will initiate major changes in lifestyles (onset or increase physical exercise, dietary changes); those who do not give their informed consent and that in the opinion of the investigator, have poor adherence or may become lost to follow-up.
Comparing the effect of two different formulations of paracetamol (effervescent or non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks treatment . The washing time between the two periods is approximately 1 week (minimum 3 days).
Drug: Non- effervescent Paracetamol kern · Drug: Effervescent paracetamol termalgin
Comparing the effect of two different formulations of paracetamol (effervescent or non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks treatment . The washing time between the two periods is approximately 1 week (minimum 3 days).
Drug: Non- effervescent Paracetamol kern · Drug: Effervescent paracetamol termalgin
1g
1 g
value of BP measured by ABPM
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.
Time frame: 3 Weeks
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina