Real-life Data of Cardiovascular Events Occuring During D... | NCT02229253

Studies
Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer

NCT02229253

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Nov 27, 2017Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Advanced Hormone Sensitive Prostate Cancer

Interventions

degarelix

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014Actual

Primary Completion Date

Oct 4, 2017Actual

Completion Date

Oct 4, 2017Actual

First Submitted Date

Aug 28, 2014

First Submission Date that Met QC Criteria

Aug 28, 2014

First Posted Date

Sep 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2017

Last Update Posted Date

Nov 27, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Degarelix		Treatment according to standard clinical practice.	Drug: degarelix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
degarelix	Drug		Degarelix	Firmagon®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients will be selected from prostate cancer patients in a hospital setting, meeting the inclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groene Hart Ziekenhuis (there may be other sites in this country)		Gouda			Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
C431566	acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided