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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05131100 | Registry Identifier | ClinicalTrials.gov |
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Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Somavert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somavert | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience adverse events | Baseline through 28 days after last dose (approximately 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience Clinical Improvement as assessed by investigator | Baseline through approximately 52 weeks |
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Inclusion Criteria:
All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.
Exclusion Criteria:
Patients who are contraindicated for Somavert
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Adult acromegaly patients who have had an inadequate response to surgery and/or radiation therapy and in whom appropriate medical treatment with somatostatin analogues did not normalize IGF-1 concentrations or was not tolerated
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Recruiting | Seoul | 01037 | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| C406545 | pegvisomant |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |