Non Interventional Study For Patients Treated With Somavert®
NCT00858143
Last updated date
ABOUT THIS STUDY
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.
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
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
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 | 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:
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2009 | |||