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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00457457 | Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms. | PHASE2 | COMPLETED | 609 | — | — | May 1, 2007 | Apr 1, 2008 | Dec 19, 2018 | 46 | Australia, Belgium +13 |
| Arm | Type | Description |
|---|---|---|
| Comparator | ACTIVE_COMPARATOR | Tamsulosin 0.4 mg prolonged release |
| Treatment Arm | EXPERIMENTAL | There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \& 100mg), UK-369,003 IR (40mg), |
| Name | Type | Description |
|---|---|---|
| Tamsulosin | DRUG | Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate |
| UK-369,003 | DRUG | UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (\>80 fold) compared to sildenafil (\~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED |
Inclusion Criteria: 1. Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13 2. Clinical diagnosis of BPH. 3. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening). Exclusion Criteria: 1. Urinary tract infection 2. P...
| 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 |