Non Interventional Study For Patients Treated With Somavert®
NCT00858143
ABOUT THIS STUDY
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- Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
- 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.
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Descriptive Information | ||||
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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 | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Serum | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study. | |||
Condition | Acromegaly | |||
Intervention | Other: Non Interventional Observation
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert® | |||
Study Groups/Cohorts | 1
Intervention: Other: Non Interventional Observation | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 311 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | January 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00858143 | |||
Other Study ID Numbers | A6291014 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | March 2009 |