Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer
Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02229253
Collaborator
(none)
112
1
37.1
3
Study Details
Study Description
Brief Summary
Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
112 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Actual Study Start Date
:
Sep 1, 2014
Actual Primary Completion Date
:
Oct 4, 2017
Actual Study Completion Date
:
Oct 4, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Degarelix Treatment according to standard clinical practice. |
Drug: degarelix
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice [Up to 1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with prostate cancer and a history of cardiovascular disease, prescribed degarelix for the treatment of their prostate cancer
Exclusion Criteria:
-
Patients who have received a form of androgen deprivation therapy for their prostate cancer, during the 12 months preceding this study are excluded
-
Planned intermittent or short-term (< 12 months) degarelix treatment
-
Planned addition of, or switch to another form of androgen deprivation therapy during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groene Hart Ziekenhuis (there may be other sites in this country) | Gouda | Netherlands |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02229253
Other Study ID Numbers:
- 000171
First Posted:
Sep 1, 2014
Last Update Posted:
Nov 27, 2017
Last Verified:
Nov 1, 2017
Additional relevant MeSH terms: