Effects of valproic acid on fibrinolysis in ma
- Conditions
- This is a healthy volunteer trial. The intended indication for the product is to investigate if upregulation of the tPA-gene by valproic acid results in increased tPA-release from endothelium in forearm.MedDRA version: 9.1Level: LLTClassification code 10016603Term: Fibrinolysis
- Registration Number
- EUCTR2009-011723-31-SE
- Lead Sponsor
- Västra Götalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Young and healthy voluntary men, aged 18-40 years.
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
Exclusion Criteria
1) Female sex
2) Smokers
3) Epilepsia
4) Hypertension
5) Malignant disease
6) Diabetes mellitus
7) BMI (body mass index) > 27 kg/m2
8) Cardiovascular disease
9) Any acute or chronic illness
10) Impaired renal or hepatic function.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if upregulation of tPA-gene by valproic acid results in increased tPA-release from endothelium in forearm.<br><br>;Secondary Objective: To evaluate ischaemia test as a method for measuring endothelial function in terms of vasodilatation and tPA-release.;Primary end point(s): T-PA release from the forearm vascular endothelium validated as release pattern (ANOVA), total t-PA release (area under the curve), peak t-PA release and time-to-peak t-PA release.
- Secondary Outcome Measures
Name Time Method