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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Shire
Information provided by (Responsible Party):
Shire Identifier:
First received: August 6, 2012
Last updated: January 12, 2017
Last verified: January 2017
As a post-approval requirement of the European Medicines Agency, this European patient pst 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).

Chronic Adrenal Insufficiency

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Incidence of intercurrent illness [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

  • Incidence of adrenal crisis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

  • Incidence of serious adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

Estimated Enrollment: 3000
Study Start Date: August 2012
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic adrenal insufficiency (primary or secondary) who are receiving Plenadren or other glucocorticoid replacement therapies at endocrinology centres in certain European countries as part of their routine clinical care. Approximately 20 sites are planned for enrollment.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01661387

Contact: Shire Contact
Contact: Shire Transparency

Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Principal Investigator: Tina Kienitz         
Endokrinologiepraxis am Stuttgarter Platz Recruiting
Berlin, Germany, 10627
Principal Investigator: Marcus Quinkler         
Friedrich Alexander Universitat Erlangen Nurnberg Recruiting
Erlangen, Germany, 91054
Principal Investigator: Flavius Zoicas         
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany, 60590
Principal Investigator: Klaus Badenhoop         
LMU Klinikum der Universität München Recruiting
Munchen, Germany, 80336
Principal Investigator: Felix Beuschlein         
Max Planck Institute für Psychiatrie Recruiting
Munchen, Germany, 80804
Principal Investigator: Gunter Stalla         
Medicover Oldenburg MVZ Recruiting
Oldenburg, Germany, 26122
Principal Investigator: Michael Droste         
Endokrinologiezentrum Ulm Praxis Not yet recruiting
Ulm, Germany, 89073
Principal Investigator: Gwendolin Etzrodt-Walter         
Universitätsklinikum Würzburg Recruiting
Wuerzburg, Germany, 97080
Principal Investigator: Stephanie Hahner         
Università degli Studi Federico II Not yet recruiting
Napoli, Italy, 80131
Principal Investigator: Rosario Pivonello         
Policlinico Umberto I Not yet recruiting
Rome, Italy, 00161
Principal Investigator: Andrea Isidori         
Policlinico Universitario Agostino Gemelli Not yet recruiting
Rome, Italy, 00168
Principal Investigator: Salvatore Corsello         
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9700
Principal Investigator: Andre van Beek         
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015
Principal Investigator: Richard Feelders         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584
Principal Investigator: Pierre Zelissen         
Sahlgrenska Universitetssjukhuset Recruiting
Gothenborg, Sweden, 413 45
Principal Investigator: Anna Nilsson         
Universitetssjukhuset i Linköping Recruiting
Linkoping, Sweden, 58185
Principal Investigator: Bertil Ekman         
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B12 2TT
Principal Investigator: Nikki Karavitaki         
St James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Robert Murray         
Barts and The London NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Principal Investigator: William Drake         
Royal Free Hospital Completed
London, United Kingdom, NW3 2QG
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Peter Trainer         
Royal Victoria Infirmary Recruiting
Newcastle, United Kingdom, NE1 4LP
Principal Investigator: Simon Pearce         
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
Principal Investigator: Ashley Grossman         
Sponsors and Collaborators
Study Director: Shire Study Physician Shire
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shire Identifier: NCT01661387     History of Changes
Other Study ID Numbers: Protocol 0918-400 
Study First Received: August 6, 2012
Last Updated: January 12, 2017
Health Authority: Sweden: Institutional Review Board
United Kingdom: National Health Service
Germany: Ethics Commission
Sweden: Regional Ethical Review Board

Keywords provided by Shire:
Adrenal insufficiency
Congenital adrenal hyperplasia (CAH)
Modified release

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Epinephryl borate
Anti-Inflammatory Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on January 14, 2017