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NCT00451958 · ClinicalTrials.gov registry record · Phase 3
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
A Phase 3 study of Prostate Cancer, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 386
- Enrollment target
- 20
- Study locations
NCT00451958: Completed Phase 3 study of Prostate Cancer, sponsored by Ferring Pharmaceuticals.
NCT00451958 is a Phase 3 study of Prostate Cancer that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 386 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00451958, a Phase 3 study of Prostate Cancer, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 386 participants
- Enrollment target
- 20
- Study locations
Study Summary
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
Primary Outcome
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
Conditions Studied
Interventions
- DRUG Degarelix 80 mg / Degarelix 80 mg
- DRUG Degarelix 160 mg / Degarelix 160 mg
- DRUG Leuprolide 7.5 mg / Degarelix 80 mg
- DRUG Leuprolide 7.5 mg / Degarelix 160 mg
Study Locations (20)
Ontario
- The Female/Male Health Centres - Barrie
- Brantford Urology Research - Brantford
- Burlington Professional Centre - Burlington
- The Urology Research Centre - Burlington
- Investigational Site - Newmarket
California
- South Orange County Medical Research Center - Laguna Hills
- Western Clinical Research - Torrance
Florida
- South Florida Medical Research - Aventura
- Investigational Site - Ocala
North Carolina
- North Urology Research - Concord
- Investigational Site - Greensboro
Alabama
- Urology Centers Of Alabama - Homewood
Colorado
- Urology Associates Research - Englewood
Louisiana
- Regional Urology - Shreveport
New Jersey
- Lawrenceville Urology - Lawrenceville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT00451958 record still lists
NCT00451958 is an interventional study that assigns participants to a tested intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Degarelix 80 mg / Degarelix 80 mg is the first listed.
NCT00451958 names 20 study sites across 13 states, led by Ontario, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00451958 about?
NCT00451958 is a clinical study titled "A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy". Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
What is the current status of trial NCT00451958?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2007-03. Estimated completion is 2011-12.
What conditions does trial NCT00451958 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00451958?
The interventions under investigation include: Degarelix 80 mg / Degarelix 80 mg (DRUG), Degarelix 160 mg / Degarelix 160 mg (DRUG), Leuprolide 7.5 mg / Degarelix 80 mg (DRUG), Leuprolide 7.5 mg / Degarelix 160 mg (DRUG).
Who is sponsoring clinical trial NCT00451958?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00451958 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00451958's enrollment target sits among peer trials
386 139th of 735 higher than 597 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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