Non Interventional Study For Patients Treated With Somavert®

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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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

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