Clinical Trials Directory

Trials / Terminated

TerminatedNCT01661387

A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

Status
Terminated
Phase
Study type
Observational
Enrollment
3,258 (actual)
Sponsor
Shire · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).

Conditions

Timeline

Start date
2012-08-07
Primary completion
2020-10-31
Completion
2020-10-31
First posted
2012-08-09
Last updated
2024-10-15

Locations

24 sites across 5 countries: Germany, Italy, Netherlands, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT01661387. Inclusion in this directory is not an endorsement.

A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI) (NCT01661387) · Clinical Trials Directory