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NCT02669771 Clinical Trial

Long-Term Specified Drug Use-Results Survey for Xtandi Capsule

Castration-resistant Prostate Cancer Clinical Trial

Official title:
Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02669771
Other study ID # 9785-MA-1018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2014
Est. completion date November 30, 2018

Study information
Verified date December 2020
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.

Recruitment information / eligibility
Status Completed
Enrollment 1018
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - no history of treatment with enzalutamide Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• enzalutamide
oral

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidences of Adverse Events Up to 2 years
Secondary Overall Survival Up to 2 years
Secondary Change from baseline in PSA value PSA: prostate-specific antigen Up to 2 years
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