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A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
This study is currently recruiting participants.
Verified January 2017 by Shire
Sponsor:
Shire
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01661387
First received: August 6, 2012
Last updated: January 26, 2017
Last verified: January 2017
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Purpose
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 |
|---|
| 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:
Genetics Home Reference related topics:
familial glucocorticoid deficiency
Genetic and Rare Diseases Information Center resources:
Hypoadrenalism
21-hydroxylase Deficiency
Congenital Adrenal Hyperplasia
U.S. FDA Resources
Further study details as provided by Shire:
Primary Outcome Measures:
- 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
| 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) |
| Groups/Cohorts |
|---|
|
Plenadren
Modified release hydrocortisone
|
| Other Glucocorticoid Replacement Therapy |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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.
Criteria
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 ClinicalTrials.gov identifier: NCT01661387
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661387
Contacts
| Contact: Shire Contact | protocol0918400@shire.com | ||
| Contact: Shire Transparency | clinicaltransparency@shire.com |
Locations
| 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 | |
Sponsors and Collaborators
Shire
Investigators
| Study Director: | Shire Physician | Shire |
More Information
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 |
| Study First Received: | August 6, 2012 |
| Last Updated: | January 26, 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 Epinephrine Racepinephrine Epinephryl borate Hydrocortisone 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 Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 23, 2017