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

Shire

Status: Terminated

Conditions: Chronic Adrenal Insufficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT01661387

0918-400

Details and patient eligibility

About

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).

Enrollment: 3,258 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic adrenal insufficiency
• Written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion criteria

• Participation in an interventional clinical trial

Trial design

3,258 participants in 2 patient groups

Plenadren

Description:

Modified release hydrocortisone

Other Glucocorticoid Replacement Therapy