One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma
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| ClinicalTrials.gov Identifier: NCT01471405 |
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Recruitment Status :
Completed
First Posted : November 15, 2011
Last Update Posted : January 11, 2019
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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Brief Summary:
This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.
| Condition or disease |
|---|
| Acromegaly |
| Study Type : | Observational |
| Actual Enrollment : | 54 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | 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 |
| Study Start Date : | January 2012 |
| Actual Primary Completion Date : | May 2013 |
| Actual Study Completion Date : | August 2013 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Proportion of patients maintained on medical treatment with lanreotide Autogel [ Time Frame: 1 year ]
- Proportion of patients receiving other medical treatments [ Time Frame: 1 year ]
Secondary Outcome Measures :
- Proportion of patients with at least one pituitary surgery [ Time Frame: 1 year ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Outpatients
Criteria
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)
Information from the National Library of Medicine
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): NCT01471405
Locations
Show 18 study locations
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
Additional Information:
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT01471405 |
| Other Study ID Numbers: |
8-79-52030-742 |
| First Posted: | November 15, 2011 Key Record Dates |
| Last Update Posted: | January 11, 2019 |
| Last Verified: | January 2019 |
Additional relevant MeSH terms:
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Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |