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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: |
NCT01471405 |
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Date of registration:
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10/11/2011 |
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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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One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma
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Scientific title:
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Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01471405 |
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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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Czech Republic
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Czechia
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France
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Germany
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Italy
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Turkey
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United Kingdom
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Contacts
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Name:
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Ipsen Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ipsen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Completed the 2-79-52030-207 study and received 12 injections of lanreotide Autogel
120 mg, regardless of efficacy at the end of this period.
- Subject or in case of subject's death next of kin having given their written informed
consent prior to collection of the data by the sponsor (if locally required)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acromegaly
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Primary Outcome(s)
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Proportion of patients maintained on medical treatment with lanreotide Autogel
[Time Frame: 1 year]
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Proportion of patients receiving other medical treatments
[Time Frame: 1 year]
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Secondary Outcome(s)
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Proportion of patients with at least one pituitary surgery
[Time Frame: 1 year]
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Secondary ID(s)
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8-79-52030-742
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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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