Gene expression profiling in skeletal muscle of healthy subjects treated with ramipril - Ram_GEP_1
- Conditions
- healthy young males
- Registration Number
- EUCTR2007-007276-41-AT
- Lead Sponsor
- Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
•Male
•Healthy defined as absence of relevant disease
•Caucasian
•Aged 18-45 years
•BMI: 18-28 kg/m2
•Signed informed consent
•Blood pressure between 110/45 and <140/90 (twice at screening)
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•History of renal artery stenosis, angioneurotic edema, psoriasis, relevant renal diseases
•RR at screening < 110/45 mmHg.
•Diabetes, history of hypertension, RR > 140/90 at screening, cardiovascular disease
•Known Diabetes mellitus of parents
•HIV or Hepatitis B/C positive virology
•Allergy or hypersensitivity against ACE-inhibitors / ramipril or to xylocain
•Contraindications against the use of the drug according to the SmPC, history of angioedema
•Any drug intake 2 weeks prior to first study day
•History of excessive bleeding tendency / hemophilia
•Presence of relevant illness within the last 3 weeks
•Suspected non-compliance with study instructions and life-style requirements
•Alcohol or drug abuse
•Blood/Plasma donation within 4 weeks prior to study day
•Previous exposure to antihypertensive drugs, ACE-inhibitors, in particular ramipril
•Current smoking (any quantity), (at least 6 months of non-smoking required)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method