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NCT05131100 Clinical Trial

Korean Regulatory Post Marketing Surveillance for Somavert

Acromegaly Clinical Trial

Official title:
Korean Post-marketing Surveillance for Somavert

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05131100
Other study ID # A6291047
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2022
Est. completion date September 15, 2026

Study information
Verified date September 2023
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 15, 2026
Est. primary completion date September 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Somavert
As provided in real world practice

Locations
Country Name City State
Korea, Republic of Pfizer Seoul

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who experience adverse events Baseline through 28 days after last dose (approximately 52 weeks)
Secondary Number of participants who experience Clinical Improvement as assessed by investigator Baseline through approximately 52 weeks
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