A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
3 other identifiers
interventional
32
7 countries
22
Brief Summary
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2021
CompletedResults Posted
Study results publicly available
May 10, 2022
CompletedMay 10, 2022
April 1, 2022
9.1 years
January 23, 2012
April 20, 2022
April 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
Up to 9 years
Study Arms (1)
Abiraterone acetate
EXPERIMENTALPatients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.
Interventions
Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
Eligibility Criteria
You may qualify if:
- Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.
You may not qualify if:
- Medical conditions that require hospitalization.
- Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Marrero, Louisiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
East Setauket, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Myrtle Beach, South Carolina, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Kogarah, Australia
Unknown Facility
Kurralta Park, Australia
Unknown Facility
South Brisbane, Australia
Unknown Facility
Subiaco, Australia
Unknown Facility
Antwerp, Belgium
Unknown Facility
Hamburg, Germany
Unknown Facility
Barcelona, Spain
Unknown Facility
Uppsala, Sweden
Unknown Facility
Newcastle upon Tyne, United Kingdom
Unknown Facility
Northwood, United Kingdom
Unknown Facility
Sutton, United Kingdom
Unknown Facility
Whitchurch, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No site qualification or initiation visits conducted for previous studies on abiraterone acetate. No formal case report forms were developed nor clinical database was generated to capture data in this study. Due to disease condition, most of participants were lost to follow-up and hence data collected was not as planned. Data were recorded based on available source notes at participating sites and thereby into CIOMS. Studied population was very small hence it was difficult to generalize results.
Results Point of Contact
- Title
- DIRECTOR CLINICAL RESEARCH
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
January 25, 2012
Study Start
March 28, 2012
Primary Completion
April 22, 2021
Study Completion
April 22, 2021
Last Updated
May 10, 2022
Results First Posted
May 10, 2022
Record last verified: 2022-04