June 4, 2008 |
December 17, 2008 |
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To assess the effect of treatment with MK0822 5 mg once daily on bone metastasis-free survival (i.e., the risk of developing a first bone metastasis or
dying from any cause) compared to placebo [ Time Frame: Approximately 36 months (event-driven study) ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00691899 on ClinicalTrials.gov Archive Site |
To assess the effect of treatment with MK0822 5 mg once daily on the risk of developing a first bone metastasis compared to placebo [ Time Frame: Approximately 36 months (event-driven study) ] [ Designated as safety issue: No ] |
Same as current |
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A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer |
A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK0822 (Odanacatib) in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer |
The purpose of this study is to investigate the effects of MK0822 in prolonging the time to first bone metastasis in men with castration-resistant prostate cancer. |
Merck Duration of Treatment : odanacatib; approximately 36 months (even driven study) - Comparator Duration of Treatment : placebo (unspecified); approximately 36 months (event driven study) |
Phase III |
Interventional |
Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Prostate Cancer |
- Drug: odanacatib
- Drug: placebo (unspecified)
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Withdrawn |
1550 |
August 2008 |
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Inclusion Criteria:
- Castration-resistant prostate cancer; increased risk for prostate cancer progression
- Patient underwent bilateral orchiectomy 6 months or more (i.e., =180 days) prior to Visit 1, or is receiving androgen-deprivation therapy and is on a stable regimen for at least 3 months (i.e., =90 days) prior to Visit 1. Androgen-deprivation therapy may include gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin
Exclusion Criteria:
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Male |
18 Years and older |
No |
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NCT00691899 |
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
MK0822-030 |
Merck |
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Study Director: |
Medical Monitor |
Merck |
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Merck |
December 2008 |