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. |
ClinicalTrials.gov Identifier: NCT01661387 |
Recruitment Status
:
Recruiting
First Posted
: August 9, 2012
Last Update Posted
: January 27, 2017
|
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Condition or disease |
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Chronic Adrenal Insufficiency |
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) |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | August 2019 |
Estimated Study Completion Date : | August 2019 |

Group/Cohort |
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Plenadren
Modified release hydrocortisone
|
Other Glucocorticoid Replacement Therapy |
- 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
- 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
- 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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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 ClinicalTrials.gov identifier (NCT number): NCT01661387
Contact: Shire Contact | protocol0918400@shire.com | ||
Contact: Shire Transparency | clinicaltransparency@shire.com |
Germany | |
Charité - Universitätsmedizin Berlin | Recruiting |
Berlin, Germany, 10117 | |
Contact: Kathrin Zopf 0049 30450 51 4019 Kathrin.Zopf@charite.de | |
Principal Investigator: Tina Kienitz | |
Endokrinologiepraxis am Stuttgarter Platz | Recruiting |
Berlin, Germany, 10627 | |
Contact: Kathrin Zopf 0049 302132004 praxis@endokrinologie-charlottenburg.de | |
Principal Investigator: Marcus Quinkler | |
Friedrich Alexander Universitat Erlangen Nurnberg | Recruiting |
Erlangen, Germany, 91054 | |
Contact: Monika Lindenberg 0049 9131853-5223 monika.lindenberg@uk-erlangen.de | |
Principal Investigator: Flavius Zoicas | |
Universitätsklinikum Frankfurt | Recruiting |
Frankfurt, Germany, 60590 | |
Contact: Maria Sandler 0049 069 6301 7818 maria.sandler@kgu.de | |
Principal Investigator: Klaus Badenhoop | |
LMU Klinikum der Universität München | Recruiting |
Munchen, Germany, 80336 | |
Contact: Susanne Schmid 0049 89 5160 5 2414 Susanne_Schmid@med.uni-muenchen.de | |
Principal Investigator: Felix Beuschlein | |
Max Planck Institute für Psychiatrie | Recruiting |
Munchen, Germany, 80804 | |
Contact: E Stettberger 0049 89 3062 2593 stettberger@mpipsukl.mpg.de | |
Principal Investigator: Gunter Stalla | |
Medicover Oldenburg MVZ | Recruiting |
Oldenburg, Germany, 26122 | |
Contact: Smadar Pahl 00 49 441 218 460 s.pahl@endokrin-ol.de | |
Principal Investigator: Michael Droste | |
Endokrinologiezentrum Ulm Praxis | Not yet recruiting |
Ulm, Germany, 89073 | |
Contact: Gwendolin Etzrodt-Walter info@endokrinologie-ulm.de | |
Principal Investigator: Gwendolin Etzrodt-Walter | |
Universitätsklinikum Würzburg | Recruiting |
Wuerzburg, Germany, 97080 | |
Contact: Martina Zink 0049 93120139968 zink_m@klinik.uni-wuerzburg.de | |
Principal Investigator: Stephanie Hahner | |
Italy | |
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 corsello.sm@mclink.it | |
Principal Investigator: Salvatore Corsello | |
Netherlands | |
Universitair Medisch Centrum Groningen | Recruiting |
Groningen, Netherlands, 9700 | |
Contact: Mariska Groeneveld 0031503612987 m.a.groeneveld@umcg.nl | |
Principal Investigator: Andre van Beek | |
Erasmus MC | Recruiting |
Rotterdam, Netherlands, 3015 | |
Contact: Sjaan Poldermans b.poldermans@erasmusmc.nl | |
Principal Investigator: Richard Feelders | |
Universitair Medisch Centrum Utrecht | Recruiting |
Utrecht, Netherlands, 3584 | |
Contact: Marjolijn Peltenburg mpeltenb@umcutrecht.nl | |
Principal Investigator: Pierre Zelissen | |
Sweden | |
Sahlgrenska Universitetssjukhuset | Recruiting |
Gothenborg, Sweden, 413 45 | |
Contact: Kristina Cid Käll 004631471249 kristina.cid.kall@vgregion.se | |
Principal Investigator: Anna Nilsson | |
Universitetssjukhuset i Linköping | Recruiting |
Linkoping, Sweden, 58185 | |
Contact: Sofia Sjoberg 0046703822234 sofia.k.sjoberg@regionostergotland.se | |
Principal Investigator: Bertil Ekman | |
United Kingdom | |
Queen Elizabeth Hospital | Recruiting |
Birmingham, United Kingdom, B12 2TT | |
Contact: Niki Karavitaki 0044 1214 158 715 niki.karavitaki@uhb.nhs.uk | |
Principal Investigator: Nikki Karavitaki | |
St James University Hospital | Recruiting |
Leeds, United Kingdom, LS9 7TF | |
Contact: Julie Lynch 0044113 20 64660 julie.lynch5@nhs.net | |
Principal Investigator: Robert Murray | |
Barts and The London NHS Trust | Recruiting |
London, United Kingdom, EC1A 7BE | |
Contact: Jane Pheby 0044 20 7882 5660 j.m.pheby@qmul.ac.uk | |
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 Victoria.Hutchinson@christie.nhs.uk | |
Principal Investigator: Peter Trainer | |
Royal Victoria Infirmary | Recruiting |
Newcastle, United Kingdom, NE1 4LP | |
Contact: Margaret Morris 0044 0191 282 0462 margaret.morris@nuth.nhs.uk | |
Principal Investigator: Simon Pearce | |
Churchill Hospital | Recruiting |
Oxford, United Kingdom, OX3 7LE | |
Contact: Violet Fazal-Sanderson 00441865 857266 violet.sanderson@ouh.nhs.uk | |
Principal Investigator: Ashley Grossman |
Study Director: | Shire Physician | Shire |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01661387 History of Changes |
Other Study ID Numbers: |
Protocol 0918-400 |
First Posted: | August 9, 2012 Key Record Dates |
Last Update Posted: | January 27, 2017 |
Last Verified: | January 2017 |
Keywords provided by Shire:
Adrenal insufficiency DuoCort Congenital adrenal hyperplasia (CAH) Modified release Hydrocortisone |
Additional relevant MeSH terms:
Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Hydrocortisone Epinephrine Racepinephrine 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 Mydriatics Sympathomimetics Vasoconstrictor Agents |