A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01661387 |
Recruitment Status :
Terminated
(Takeda submitted 900 patient years Interim Analysis to PRAC and requested study to be closed since primary objective had been fulfilled. PRAC agreed and on 17Sep2020 approved closure of EU-AIR Registry. Takeda announced study closure on 31Oct2020.)
First Posted : August 9, 2012
Last Update Posted : November 23, 2020
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Condition or disease |
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Chronic Adrenal Insufficiency |
Study Type : | Observational |
Actual Enrollment : | 3258 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 |
Actual Primary Completion Date : | October 31, 2020 |
Actual Study Completion Date : | October 31, 2020 |

Group/Cohort |
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Plenadren
Modified release hydrocortisone
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Other Glucocorticoid Replacement Therapy |
- Incidence of intercurrent illness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: approximately 10 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, Older Adult |
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

Study Director: | Shire Director | Shire |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01661387 |
Other Study ID Numbers: |
0918-400 |
First Posted: | August 9, 2012 Key Record Dates |
Last Update Posted: | November 23, 2020 |
Last Verified: | November 2020 |
Adrenal insufficiency DuoCort Congenital adrenal hyperplasia (CAH) Modified release Hydrocortisone |
Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases |