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

Terminated

• Conditions: Chronic Adrenal Insufficiency

• Registration Number: NCT01661387
• Lead Sponsor: Shire

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-06
• Study Start: 2012-08-07
• Study First Posted: 2012-08-09
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3258

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of intercurrent illness	approximately 10 years	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of adrenal crisis	approximately 10 years	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of serious adverse events	approximately 10 years	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

Trial Locations

Locations (24)

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, Germany

Università degli Studi Federico II; 🇮🇹 Napoli, Italy

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