EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 49
- 主要终点
- value of BP measured by ABPM
研究概览
简要总结
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)
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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)
排除标准
- •Patients with allergy, intolerance or contraindication to paracetamol or tramadol will be excluded, as those who have taken nonsteroidal antiinflammatory drugs (NSAIDs) orally or parenterally in the last week, or have a high degree of pain (VAS> 4) or poorly controlled hypertension (office BP> 150/95 mmHg or daytime ambulatory mean BP > 140/90 mmHg).
- •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.
研究组 & 干预措施
Non-effervescent tablets
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).
干预措施: Non- effervescent Paracetamol kern (Drug)
Non-effervescent tablets
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).
干预措施: Effervescent paracetamol termalgin (Drug)
Effervescent Paracetamol
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).
干预措施: Non- effervescent Paracetamol kern (Drug)
Effervescent Paracetamol
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).
干预措施: Effervescent paracetamol termalgin (Drug)
结局指标
主要结局
value of BP measured by ABPM
时间窗: 3 Weeks
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.
次要结局
未报告次要终点