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

Chronic Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01661387
• Other study ID #: 0918-400
• Status: Terminated
• Start date: August 7, 2012
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2020
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3258
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Chronic Adrenal Insufficiency

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Endokrinologiepraxis am Stuttgarter Platz	Berlin
Germany	Friedrich Alexander Universitat Erlangen Nurnberg	Erlangen
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	LMU Klinikum der Universität München	Munchen
Germany	Medicover Neuroendokrinologie	Munchen
Germany	Medicover Oldenburg MVZ	Oldenburg
Germany	Endokrinologiezentrum Ulm Praxis	Ulm
Germany	Universitätsklinikum Würzburg	Wuerzburg
Italy	Università degli Studi Federico II	Napoli
Italy	Policlinico Umberto I	Rome
Italy	Policlinico Universitario Agostino Gemelli	Rome
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Erasmus MC	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Sweden	Sahlgrenska Universitetssjukhuset	Gothenborg
Sweden	Universitetssjukhuset i Linköping	Linkoping
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	St James University Hospital	Leeds
United Kingdom	Barts and The London NHS Trust	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Christie Hospital	Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle
United Kingdom	Churchill Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intercurrent illness	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI	approximately 10 years
Primary	Incidence of adrenal crisis	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI	approximately 10 years
Primary	Incidence of serious adverse events	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI	approximately 10 years