Brief Title
Non Interventional Study For Patients Treated With Somavert®
Official Title
German Non Interventional Study For Patients Treated With Somavert®
Brief Summary
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.
Detailed Description
Non probability samples
Study Type
Observational
Primary Outcome
Serious Adverse Events (SAE) and Adverse Events (AE)
Secondary Outcome
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Condition
Acromegaly
Intervention
Non Interventional Observation
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
311
Start Date
January 2004
Completion Date
January 2008
Primary Completion Date
January 2008
Eligibility Criteria
Inclusion Criteria: - Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study. Exclusion Criteria: - Subjects treated with an investigational drug for treatment of acromegaly. - Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery. - Women who were pregnant or lactating.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Administrative Informations
NCT ID
NCT00858143
Organization ID
A6291014
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
March 2009