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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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12 December 2020 |
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Main ID: |
NCT01580605 |
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Date of registration:
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13/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
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Scientific title:
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Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started |
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Date of first enrolment:
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July 17, 2003 |
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Target sample size:
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331 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01580605 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult with growth hormone deficiency
- Treated with Norditropin® SimpleXx (somatropin)
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adult Growth Hormone Deficiency
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Growth Hormone Disorder
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Intervention(s)
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Drug: somatropin
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Primary Outcome(s)
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Body mass index (BMI)
[Time Frame: Once a year for 5 years]
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Weight
[Time Frame: Once a year for 5 years]
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Body composition
[Time Frame: Once a year for 5 years]
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Waist:Hip Ratio
[Time Frame: Once a year for 5 years]
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Secondary Outcome(s)
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Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides
[Time Frame: Once a year for 5 years]
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IGF-1 (Insulin-like growth factor 1) concentration
[Time Frame: Once a year for 5 years]
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Dose prescribed
[Time Frame: Once a year for 5 years]
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Secondary ID(s)
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GHDA-1755
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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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