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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00858143 |
This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.
Condition | Intervention | Phase |
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Acromegaly |
Other: Non Interventional Observation |
Phase IV |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | German Non Interventional Study For Patients Treated With Somavert® |
Serum
Enrollment: | 311 |
Study Start Date: | January 2004 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 |
Other: Non Interventional Observation
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
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Non probability samples
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6291014 |
Study First Received: | March 6, 2009 |
Results First Received: | June 25, 2009 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00858143 History of Changes |
Health Authority: | Germany: Ethikkommission Ethikausschuss 1 am Campus Charité Mitte |
Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study |
Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Musculoskeletal Diseases Endocrine System Diseases |
Central Nervous System Diseases Endocrinopathy Brain Diseases Bone Diseases Acromegaly |
Bone Diseases, Endocrine Hypothalamic Diseases Hyperpituitarism Pituitary Diseases Musculoskeletal Diseases Nervous System Diseases |
Endocrine System Diseases Central Nervous System Diseases Brain Diseases Bone Diseases Acromegaly |