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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01661387
Recruitment Status : Recruiting
First Posted : August 9, 2012
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):

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).

Condition or disease
Chronic Adrenal Insufficiency

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Study Type : Observational
Estimated Enrollment : 3000 participants
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)
Actual Study Start Date : August 7, 2012
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2022

Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01661387

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Contact: Shire Contact +1 866-842-5335

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Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Kathrin Zopf    0049 30450 51 4019   
Principal Investigator: Tina Kienitz         
Endokrinologiepraxis am Stuttgarter Platz Recruiting
Berlin, Germany, 10627
Contact: Kathrin Zopf    0049 302132004   
Principal Investigator: Marcus Quinkler         
Friedrich Alexander Universitat Erlangen Nurnberg Recruiting
Erlangen, Germany, 91054
Contact: Monika Lindenberg    0049 9131853-5223   
Principal Investigator: Flavius Zoicas         
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany, 60590
Contact: Maria Sandler    0049 069 6301 7818   
Principal Investigator: Klaus Badenhoop         
LMU Klinikum der Universität München Recruiting
Munchen, Germany, 80336
Contact: Susanne Schmid    0049 89 5160 5 2414   
Principal Investigator: Felix Beuschlein         
Max Planck Institute für Psychiatrie Recruiting
Munchen, Germany, 80804
Contact: E Stettberger    0049 89 3062 2593   
Principal Investigator: Gunter Stalla         
Medicover Oldenburg MVZ Recruiting
Oldenburg, Germany, 26122
Contact: Smadar Pahl    00 49 441 218 460   
Principal Investigator: Michael Droste         
Endokrinologiezentrum Ulm Praxis Not yet recruiting
Ulm, Germany, 89073
Contact: Gwendolin Etzrodt-Walter   
Principal Investigator: Gwendolin Etzrodt-Walter         
Universitätsklinikum Würzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Martina Zink    0049 93120139968   
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
Contact: Salvatore Corsello   
Principal Investigator: Salvatore Corsello         
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9700
Contact: Mariska Groeneveld    0031503612987   
Principal Investigator: Andre van Beek         
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015
Contact: Sjaan Poldermans   
Principal Investigator: Richard Feelders         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584
Contact: Marjolijn Peltenburg   
Principal Investigator: Pierre Zelissen         
Sahlgrenska Universitetssjukhuset Recruiting
Gothenborg, Sweden, 413 45
Contact: Kristina Cid Käll    004631471249   
Principal Investigator: Anna Nilsson         
Universitetssjukhuset i Linköping Recruiting
Linkoping, Sweden, 58185
Contact: Sofia Sjoberg    0046703822234   
Principal Investigator: Bertil Ekman         
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B12 2TT
Contact: Niki Karavitaki    0044 1214 158 715   
Principal Investigator: Nikki Karavitaki         
St James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Julie Lynch    0044113 20 64660   
Principal Investigator: Robert Murray         
Barts and The London NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Contact: Jane Pheby    0044 20 7882 5660   
Principal Investigator: William Drake         
Royal Free Hospital Completed
London, United Kingdom, NW3 2QG
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Victoria Hutchinson    0044 (0)161 446 8132   
Principal Investigator: Peter Trainer         
Royal Victoria Infirmary Recruiting
Newcastle, United Kingdom, NE1 4LP
Contact: Margaret Morris    0044 0191 282 0462   
Principal Investigator: Simon Pearce         
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Violet Fazal-Sanderson    00441865 857266   
Principal Investigator: Ashley Grossman         
Sponsors and Collaborators
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Study Director: Shire Director Shire

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shire Identifier: NCT01661387     History of Changes
Other Study ID Numbers: 0918-400
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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

Additional relevant MeSH terms:
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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