EUCTR2015-002060-17-FR进行中（未招募）1 期
Effect of pharmacological heart rate reduction on visco-elastic properties of the arterial wall - Impact of aging - BRADY-VASC
CHU - Hôpitaux de Rouen0 个研究点目标入组 30 人开始时间: 2015年8月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy subject
- •Aged between 25 and 65 years old
- •Resting heart rate mesured three times after a rest period of 15 min = 70 bpm
- •No significant ECG abnormality
- •No significant biological abnormality
- •Childbearing age women must have effective contraception (estrogen-progestin contraceptives, intrauterin device or tubal ligation). Will be considered postmenopausal women with amenorrhea for more than 2 years
- •Able to read and understand information form and to give written informed consent
- •Subjects with medical insurance
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who don’t understand French language
- •Subjects deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)
- •Pregnant women, nursing mother or women without contraception
- •Subjects who participate to an other trial / participated to an other interventional research without drugs during the last month or a trial with drugs during the last 3 months
- •Hypersensitivity to the active substance or to any of the excipients
- •Congenital galactosemia, lactase deficiency (Lapp), malabsorption of glucose and galactose
- •Severe hypotension, mesured three times after a rest period of 15 min (< 90/50 mmHg)
- •Essential or secondary hypertension, mesured three times after a rest period of 15 min (SBP =140 mmHg and/or DBP =90 mmHg)
- •Smoking at the day of inclusion (>5 cigarettes/day)
- •Severe hypercholesterolemia (Total cholesterol >2,5 g/L)
- •Subjects who practice sports intensively (= 1 hour/day)
- •Renal insufficiency (creatinine clearance = 60 ml/min/1,73 m² Cockroft and Gault formula)
- •Known liver failure
- •Known heart failure or suspected heart failure (congestive episode)
- •Atrial fibrillation
- •High-grade conduction block (Sick sinus syndrome, sino-atrial block or grade 2 or 3 atrio-ventricular block)
- •Abnormal corrected QT with Bazett formula (cQT > 450 ms (men) or > 470 ms (women)).
- •All cardiac or no cardiac diseases, active or with sequelae, which, in the opinion of the investigator, is accompanied by a risk of cardiac or vascular abnormality
- •Known retinal disease
- •Subject disagrees with the prohibition of taking grapefruit juice, millepertuis or any medication during the study except oral contraceptive, acetaminophene or decision of the investigator. (annex n°02)
- •Administration of any medication listed in anex n°02 (aspirin, NSAID and inhibitors of cytochrome P450 3A4) during the previous week.
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