Calcitonin Gene-Related Peptide Receptor Antagonists for Prevention of Acute Mountain Sickness

niversitätsklinikum Essen0 个研究点目标入组 30 人开始时间: 2023年1月13日最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•- Age 18-60 years
•- Good physical condition
•- No relevant pathologies revealed upon the pre-examination prior to the study
•- Written informed consent to participate in the study
•- Permanent residency below 1000 m
•- Males and females are included without prioritization
•- More than 3 weeks since vaccination against or full recovery from SARS-CoV2 infection
•- Negative serum or urine pregnancy test in women of childbearing potential if pregnancy cannot be ruled out
•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

•- Intolerance against erenuma or any drug component
•- Acute and chronic lung diseases
•- Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease)
•- Conventional systolic blood pressure =150 mmHg and conventional diastolic blood pressure =95 mmHg (average of two measurements) in untreated or treated subjects
•- Chronic headache / migraine
•- Diabetes mellitus
•- Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
•- Alcohol (>30 g/d) or drug abuse
•- Obesity (Body Mass Index >30)
•- Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders, Parkinson disease, pheochromocytoma)
•- Sojourn >2000 m within the last 8 weeks before the 1st study day
•- Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti-coagulants)
•- Blood donation within the last 2 month before the 1st study day
•- Pregnant or nursing women
•- Participation in other clinical trials

发起方

niversitätsklinikum Essen