An open, multi-centre, phase IIIb, long term follow-up study to assess the safety, tolerability and efficacy of once-daily oral modified-release hydrocortisone in patients with adrenal insufficiency.

DuoCort Pharma AB0 个研究点目标入组 86 人开始时间: 2008年7月3日最近更新: 2015年2月23日

试验速览

暂无简介。

•- Males and females; age 18 years and above.
•- Previously diagnosed (e.g. more than 6 months ago) primay adrenal insufficiency with a stable daily glucocorticoid substitution dose of at least 3 months prior to study entry.
•- An oral hydrosortisone substitution therapy dose of 15-40 mg total dialy dose.
•- Signed informed consent to participate in the study.
•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

•- Clinical or laboratory signs of sigificant cerebral, cardiovascular, respiratory, hepatiobiliary, pancreatic disease, which in the investigators judgment may interfere with the study assessment or completion of the study.
•- Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L.
•- Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids.
•- Administration of other investigational drugs within eight weeks preceding the preentry examination.
•- Alcohol/drug abuse or any condition associated with poor patient compliance, including expected non-cooperation, as judged by investigator.
•- Regular DHEA medication for the past 4 weeks.
•- Deranged mineralcorticoid status as determined by clinical (hypotension, ortostatic hypotension) and biochemical status (serum sodium and potassium level).

发起方