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Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01215513
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Collaborator:
Ferring Pharmaceuticals Korea, Ltd.
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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Brief Summary:
This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy
Study Start Date : September 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety
Drug Information available for: Degarelix

Arms and Interventions
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Arm Intervention/treatment
Experimental: Degarelix Drug: Degarelix


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: From baseline (day 0) to end of treatment (up to day 364) ]

    The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study.

    ULN=upper limit of normal


  2. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: From baseline (day 0) to end of treatment (up to day 364) ]
    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

  3. Number of Participants With Markedly Abnormal Values in ECG Variables [ Time Frame: From baseline (day 0) to end of treatment (up to day 364) ]
    This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.


Secondary Outcome Measures :
  1. Serum Levels of Prostate Specific Antigen (PSA) Over Time [ Time Frame: Day 0, day 196, day 280, and day 364 ]
    PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
  • Has completed the 7-month main trial, FE200486 CS42

Exclusion Criteria:

  • Has been withdrawn/discontinued from the FE200486 CS42 trial
  • A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215513


Locations
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Korea, Republic of
Korea University Hospital
Seoul, Anam-dong, Seongbuk-gu, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, Korea, Republic of
Yonsei University Health System Gangnam Sevrance
Seoul, Eonguro, Gangnam-gu, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of
Hallym University Sacred Heart Hospital
Pyungchon, Gyunggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
Mulgeum-eup, Gyungnam, Korea, Republic of
Samsung Medical Center
Seoul, Ilwon-dong, Kangnam-gu, Korea, Republic of
Asan Medical Center
Seoul, Pungnap-2-dong, Songpa-gu, Korea, Republic of
Yonsei University Health System (Sevrance Hospital)
Seoul, Seongsanno, Seodaemun-gu, Korea, Republic of
Seoul National University Hospital
Seoul, Yeongeon-dong, Chongno-gu, Korea, Republic of
Kyoungbuk National University Hospital
Daegu, Korea, Republic of
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Pharmaceuticals Korea, Ltd.
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01215513    
Other Study ID Numbers: FE200486 CS42A
First Posted: October 6, 2010    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: May 22, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases