Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00090103 | Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment | PHASE3 | COMPLETED | 4,844 | — | — | Nov 1, 2003 | Apr 1, 2009 | Feb 28, 2017 | 503 | United States, Argentina +35 |
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.
| Arm | Type | Description |
|---|---|---|
| dutasteride | ACTIVE_COMPARATOR | dutasteride 0.5mg once daily |
| Combo | EXPERIMENTAL | Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily |
| tamsulosin | ACTIVE_COMPARATOR | tamsulosin 0.4mg once daily |
| Name | Type | Description |
|---|---|---|
| dutasteride 0.5mg once daily for 4 years | DRUG | combination or single agent |
| tamsulosin 0.4mg once daily for 4 years | DRUG | combination agent or single agent |
Inclusion criteria: * A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: * males, aged ≥50 years * clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) * International Prostate...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 2 | — | Undisclosed |
| PROCEPT BioRobotics Corp. | PRCT | 2 | NA | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | NA | Undisclosed |
| Profound Medical Corp | PROF | 1 | — | Undisclosed |