Safety and Efficacy of Lorbrena
Special Investigation for LORBRENA Tablets
2 other identifiers
observational
1,290
1 country
1
Brief Summary
To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug
- 1.Factors affecting the onset of central nervous system disorder
- 2.Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2019
CompletedFirst Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedSeptember 4, 2025
September 1, 2025
6.5 years
February 15, 2019
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction
52 weeks
Eligibility Criteria
683 patients
You may qualify if:
- All administered patients
You may not qualify if:
- Nothing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
3-22-7, Yoyogi, Shibuya-ku
Tokyo, 151-8589, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 18, 2019
Study Start
January 21, 2019
Primary Completion
July 30, 2025
Study Completion
July 30, 2025
Last Updated
September 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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.