Non Interventional Study For Patients Treated With Somavert®

NCT00858143

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
 (submitted: March 6, 2009)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009