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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229253
Other study ID # 000171
Secondary ID
Status Completed
Phase N/A
First received August 28, 2014
Last updated November 23, 2017
Start date September 2014
Est. completion date October 4, 2017

Study information

Verified date November 2017
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date October 4, 2017
Est. primary completion date October 4, 2017
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
degarelix


Locations

Country Name City State
Netherlands Groene Hart Ziekenhuis (there may be other sites in this country) Gouda

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice Up to 1 year