Status:
COMPLETED
Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
Lead Sponsor:
Medical University of Vienna
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE4
Brief Summary
This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake. This should c...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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 3 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)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00657865
Start Date
March 1 2008
End Date
August 1 2011
Last Update
August 22 2011
Active Locations (1)
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1
Medical University Vienna, Department of Clinical Pharacology
Vienna, Vienna, Austria, 1090