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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT01771328 |
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Date of registration:
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10/01/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia
CAH |
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Scientific title:
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Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01771328 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Norway
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Contacts
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Name:
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Kristian Løvås, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Haukeland University Hospital, Department of Medicine |
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Name:
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Kristian Løvås, MD, PhD |
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Address:
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Telephone:
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+47 55977996 |
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Email:
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kral@helse-bergen.no |
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Affiliation:
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Name:
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Kristian Løvås, MD, PhD |
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Address:
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Telephone:
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+4755977996 |
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Email:
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kral@helse-bergen.no |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- verified salt-wasting CAH and simple virilizing CAH, on single prednisone, or
hydrocortisone therapy.
- In case of concomitant endocrine/autoimmune diseases these should be on stable
treatment during the study period.
Exclusion Criteria:
- Patients with diabetes mellitus on insulin pump treatment will not be included in
this study
- cardiovascular disease, active malignant disease and pregnancy, and pharmacological
treatment with glucocorticoids or drugs that interfere with cortisol metabolism
(antiepileptics, rifampicin, St. Johns wart).
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adrenal Hyperplasia, Congenital
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Intervention(s)
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Drug: Cortisone acetate
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Drug: Hydrocortisone
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Primary Outcome(s)
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Androgen levels
[Time Frame: 3 months]
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Secondary Outcome(s)
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c-reactive protein
[Time Frame: 4 months]
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waist circumference
[Time Frame: 3 month]
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Dual-energy X-ray absorptiometry (DXA)
[Time Frame: 6 months]
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fasting glucose
[Time Frame: 4 months]
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hip circumference
[Time Frame: 3 months]
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Steroid metabolism
[Time Frame: 4 months]
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bone metabolism
[Time Frame: 3 months]
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blood pressure
[Time Frame: 3 months]
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fasting insulin
[Time Frame: 3-4 months]
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body mass index
[Time Frame: 3 months]
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Subjective health status
[Time Frame: 3 months]
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glycated haemoglobin (Hb1AC)
[Time Frame: 4 months]
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lipid levels
[Time Frame: 4 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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