Trial · NCT01666314
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan | Baseline and Week 4 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan | Baseline and Week 4 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Baseline and Week 4 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment | Baseline and Week 12 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment | Baseline and Week 4 | A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. |
| Secondary | Percentage of Participants With PSA50 After 12 Weeks of Treatment | Baseline and Week 12 | A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. |
| Secondary | Absolute Values for Testosterone | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory. |
| Secondary | Absolute Values for Adrenocorticotropic Hormone (ACTH) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum ACTH was measured by immunometric assay at the central laboratory. |
| Secondary | Absolute Values for Corticosterone | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory. |
| Secondary | Absolute Values for Cortisol | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum Cortisol was measured by immunometric assay at the central laboratory. |
| Secondary | Absolute Values for Prostate-Specific Antigen (PSA) | Baseline and Cycle 2 Day 1 | Serum PSA was measured at the central laboratory. |
| Secondary | Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite | Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. |
| Secondary | AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite | Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study. |
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite | Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. |
| Secondary | AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite | Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | Cumulative amount of urine excreted time 0 to 24 hour. |
| Secondary | Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite | Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | Maximum observed steady-state plasma concentration during a dosing interval. |
| Secondary | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite | Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state. |
| Secondary | AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite | Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval. |
| Secondary | Rac: Accumulation Index for Orteronel and M-I Metabolite | Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose | Rac was calculated as the ratio of AUCtau to AUC12hr. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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