Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQ
- Conditions
- We aim to study patients with cortisol deficiency caused by primary adrenal insufficiency (Addison’s disease of autoimmune origin).
- Registration Number
- EUCTR2005-001768-30-SE
- Lead Sponsor
- EM-kliniken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
1) Cortisol plasma level < 300 nmol/L during stimulation test
2) ACTH > 300 ng/L
3) Age > 18 years
4) Informed concent
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) Chronic severe disease with risk of deterioration that can influence the cortisol substitution program
2) Chronic drug abuse
3) suspicion of non compliance
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