Status:
TERMINATED
Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression
Lead Sponsor:
Rennes University Hospital
Conditions:
Renin Angiotensin
Eligibility:
MALE
20-30 years
Phase:
PHASE1
PHASE2
Brief Summary
Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonst...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Men between 20 and 30 years
- Body Mass Index between 18 kg/m² and 25 kg/m²
- Normal clinical examination
- Normal biological variables
- Normal electrocardiogram and echocardiography
- Written, voluntary informed consent
- Non smoker since at least a year
- Non-inclusion Criteria:
- Any history of significant allergy
- Subjects with abnormal renal, pulmonary, cardiovascular, endocrine or hepatic function
- Medication during the study
- Alcohol consumption more than 30g/day or drug addiction
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
- Exclusion period mentioned on the Healthy Volunteers National list
- Persons deprived of freedom or under guardianship
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00673270
Start Date
May 1 2008
End Date
March 1 2009
Last Update
March 2 2012
Active Locations (1)
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1
Unité d'Investigation Clinique - Hôpital de Pontchaillou
Rennes, France, 35033