EUCTR2006-004396-35-GB
Active, not recruiting
Phase 1
Investigation of the anti-inflammatory effects of simvastatin in a model of acute lung injury after inhalation of lipopolysaccharide by healthy volunteers - Statins in a model of acute lung injury in healthy volunteers
Belfast City Hospital Trust0 sitesSeptember 18, 2006
ConditionsAcute lung injury (ALI)
Drugssimvastatin 40mg
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute lung injury (ALI)
- Sponsor
- Belfast City Hospital Trust
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy non\-smoking subjects
- •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)
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •age \< 18 years
- •creatinine kinase (CK) \> 5 times upper limit normal range
- •known active liver disease, alcohol abuse or abnormal liver function tests: transaminases \> 3 times upper limit normal range
- •renal impairment (calculated creatinine clearance less than 60mL/minute)
- •known lactose intolerance
- •history of asthma
- •participation in other trials within 30 days
- •pregnancy, breast\-feeding or women of childbearing potential not using adequate contraception;
- •current treatment with statins
- •known hypersensitivity to the study medication
Outcomes
Primary Outcomes
Not specified
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