Non Interventional Study For Patients Treated With Somavert®

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Non probability samples

Conditions

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Acromegaly

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Non Interventional Observation

Intervention Type OTHER

Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

Interventions

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Non Interventional Observation

Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No