NCT02278302已完成1 期
Placebo-controlled, Randomized, Double-blind Study Comparing the Effect of a Combination of 200 mg Dipyridamole With Sustained Release and 25 mg Acetyl Salicylic Acid (Aggrenox®) on the Performance Relevant to Safety and on the General Condition of Volunteers and 10 Days of Treatment Alone and in Combination With Alcohol (Study no. 591002)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Change in safety relevant performance in the steady state represented and scored by five psychomotor tests
研究概览
简要总结
Study to investigate whether psychomotor performance which is necessary for safety driving a car or operating machinery and safely participating in daily life is changed by Aggrenox®. Also to investigate whether Aggrenox® impairs performance in combination with alcohol more than alcohol alone. Derived from this: Statement on whether a warning for drivers is necessary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Race: Caucasian
- •Men and women aged between 40 and 65 years
- •Written and spoken command of German
- •Ability to understand the nature and significance of the study
- •Written informed consent to participate in the study
排除标准
- •Acute disease at the beginning of the study
- •Any chronic disease in particular:
- •Diseases for which the administration of the test drug was contraindicated:
- •Severe coronary heart disease (e.g. unstable angina pectoris or recent myocardial infarction)
- •Subvalvular aortic stenosis or hemodynamic instability, myocardial decompensation
- •Severe hypotension, hypotonic collapse
- •Any other cardiac disease (or case history of)
- •Chronic obstructive lung disease
- •Hepatic and renal dysfunction
- •Diseases of the gastrointestinal tract
- •Mental or neurologic diseases
- •Alcoholism, alcohol abuse
- •Case history of clinically relevant allergies (particularly against one of the ingredients of the test substance incl. paracetamol)
- •Participation in another clinical study during the last two months preceding the study
- •Women while pregnant or breastfeeding
- •Women of childbearing age without safe contraception
- •Psychotropic drugs during the last four weeks before the beginning of and during the study
- •taking other medicaments regularly during the last two weeks before the beginning of and during the study (except for oral contraceptives, hormone replacement in women)
- •Body weight outside the Body-Mass-Index (BMI) +- 4
- •Habits of life style having a presumable negative effect on the results of the performance test (e.g. shift work, extreme sports, blood donation within the last 4 weeks, > 8 cups/glasses of caffeine-containing beverages/day, > 40 g alcohol/day, >40 cigarettes/day)
- •positive or no drug screening for barbiturates, benzodiazepines, tricyclic antidepressants and cannabinoids, amphetamines, cocaine, opiates
- •Persons having been detained in an institution by judicial or official order
- •Persons incapacitated or placed under provisional guardianship
研究组 & 干预措施
Aggrenox®
Experimental
treatment alone or in combination with Ethanol
干预措施: Aggrenox® (Drug)
Aggrenox®
Experimental
treatment alone or in combination with Ethanol
干预措施: Ethanol (Other)
Placebo
Placebo Comparator
treatment alone or in combination with Ethanol
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
treatment alone or in combination with Ethanol
干预措施: Ethanol (Other)
结局指标
主要结局
Change in safety relevant performance in the steady state represented and scored by five psychomotor tests
时间窗: up to day 11
motor coordination, reaction under stress, concentration, vigilance, precision and visual orientation
次要结局
- Change in concentration by means of psychomotor test (SIGNAL)(up to day 11)
- Number of subjects with adverse events(up to 25 days)
- Number of subjects with abnormal changes in laboratory parameters(up to day 11)
- Change in precision and visual orientation by means of psychomotor test (TAVT33)(up to day 11)
- Change in motor coordination by means of psychomotor test (2HAND)(up to day 11)
- Change in reaction under stress by means of psychomotor test (DT)(up to day 11)
- Number of subjects with abnormal changes in vital parameters(up to day 11)
- Change in general condition rated on 4-point scales(up to day 11)
- Change in vigilance by means of psychomotor test (VIGIL)(up to day 11)
研究者
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