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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00408954 | Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms | PHASE2 | COMPLETED | 27 | — | — | Mar 1, 2007 | Jun 1, 2008 | Nov 23, 2010 | 11 | Czechia, Netherlands +1 |
| NCT00814736 | A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031 | PHASE1 | COMPLETED | 22 | — | — | Aug 1, 2008 | Sep 1, 2008 | Dec 25, 2008 | 1 | Singapore |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| UK-369,003 | ACTIVE_COMPARATOR | - |
| UK369,003 + Placebo or sildenafil | EXPERIMENTAL | All subjects will receive 17 days daily dosing of UK-369,003 100 mg MR Subjects will receive single oral doses of the following interactant treatments in a randomized order On Day 14, a single dose of sildenafil-matching placebo or 100 mg sildenafil and on Day 17 a single dose of 100 mg sildenafil or a sildenafil matching placebo |
| Name | Type | Description |
|---|---|---|
| UK-369,003 | DRUG | 100 mg MR tablet once daily for 2 weeks |
| UK369,003 | DRUG | oral tablet, once a day |
| sildenafil | DRUG | single oral dose on day 14 or day 17 |
| sildenafil matching placebo | DRUG | single oral dose on day 14 or day 17 |
Inclusion Criteria: * Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13. * Clinical diagnosis of BPH * Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml * Urodynamically defined bladder outlet obstruction Exclusion Criteria: * 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 |