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Non Interventional Study For Patients Treated With Somavert®

Last updated on November 14, 2019

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Study Location
Contact
1-800-718-1021
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.
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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.

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.

NCT00858143
Pfizer
Completed
Non Interventional Study For Patients Treated With Somavert®

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Descriptive Information
Brief TitleNon Interventional Study For Patients Treated With Somavert®
Official TitleGerman Non Interventional Study For Patients Treated With Somavert®
Brief SummaryThis 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 DescriptionNon probability samples
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
Serum
Sampling MethodNon-Probability Sample
Study PopulationSubjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
ConditionAcromegaly
InterventionOther: Non Interventional Observation
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
Study Groups/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: March 6, 2009)
311
Original Actual EnrollmentSame as current
Actual Study Completion DateJanuary 2008
Actual Primary Completion DateJanuary 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00858143
Other Study ID NumbersA6291014
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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